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Procalcitonin guided antibiotic therapy of astute exacerbations of asthma: a randomized controlled trial

BMC Infectious Diseases volume thirteen, Article number:596 (2013) Cite this article

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Abstract

Groundwork

This randomized controlled trial aimed to evaluate whether the serum procalcitonin (PCT) level tin be utilized to guide the apply of antibiotics in the handling of acute exacerbations of asthma.

Methods

A total of 293 consecutive patients with suspected asthma attacks from Feb 2005 to July 2010 participated in this study. 225 patients completed the study. Serum Per centum levels, and other inflammatory biomarkers of all patients were measured. In addition to the standard treatment, the control group received antibiotics according to the attention physicians' discretions, while the patients in the PCT group were treated with antibiotics according to serum PCT concentrations. Antibiotics usage was strongly discouraged when the PCT concentration was below 0.1 μg/Fifty; discouraged when the PCT concentration was betwixt 0.1 μg/L and 0.25 μg/L; or encouraged when the PCT concentration was above 0.25 μg/Fifty. The primary endpoint was the conclusion of antibiotics usage. The second endpoints included the diagnostic accuracy of PCT and other laboratory biomarkers the effectiveness of asthma control, secondary ED visits, infirmary re-admissions, repeated needs for steroids or dosage increment, needs for antibiotics, WBC count, Percent levels and FEV1%.

Results

At baseline, ii groups were identical regarding clinical, laboratory and symptom score. Probability of the antibiotics usage in the Percentage group (46.1%) was lower than that in the command grouping (74.8%) (χii = 21.97, p < 0.001. RR = 0.561, 95% CI 0.441-0.713). Pct and IL-vi showed good diagnostic significance for bacterial asthma (r = 0.705, p = 0.003). The degrees of asthma control in patients were categorized to 3 levels and were comparable between the two groups at the half-dozen weeks follow-up menstruation (χ2 = i.62, p = 0.45). There were no significant difference regarding other secondary outcomes (p > 0.05).

Conclusions

The serum Percent concentration tin can be used to effectively decide whether the astute asthma patients take bacterial infections in the respiratory tract, and to guide the utilise of antibiotics in the handling of acute asthma exacerbations, which may substantially reduce unnecessary antibiotic utilise without compromising the therapeutic outcomes.

Trial registration

ICTRP%20ChiCTR-TRC-12002534

Peer Review reports

Background

Acute attacks of asthma are episodes that occur suddenly and may also occur repeatedly over time. The attacks seriously disturb the patient'due south daily and work life, which impose great burdens on the family unit and the society. In that location are various causes for astute asthma, including allergen provocation, drugs, respiratory viruses, bacterial infections and and so on. Since bacterial infection seems to but play a minor role in astute exacerbations of asthma, guidelines for asthma management practise non recommend routine use of antibiotics [i]. The majority of patients with acute asthma are treated with a number of conventional treatment measures, including repetitive administration of rapid-interim inhaled bronchodilator, introduction of systemic glucocorticosteroids, oxygen supplementation and so on, to alleviate the symptoms. Notwithstanding, clinical signs and symptoms and laboratory parameters of bacterial infection are often inconclusive, which makes it difficult for physicians to determine accurately in clinical exercise whether there is bacterial infection in the respiratory tracts of patients. Equally a event, almost patients are treated with antibiotics, leading to antibiotics corruption and bacterial resistance [2].

Procalcitonin (PCT) is the prehormone of calcitonin. The serum Percentage level significantly increases in patients with bacterial infections simply not viral infection or other inflammatory diseases, granting the PCT test high potential in discriminating bacterial and not-bacterial infections [3–5]. Therefore, the serum Percent level can guide the use of antibiotics in respiratory tract infections to foreclose the corruption of antibiotics in the intensive care unit [6–15]. This written report aimed to investigate whether the serum PCT level has diagnostic potential for bacterial asthma attack, and tin serve to guide the utilise of antibiotics in the management of acute exacerbations of asthma.

Methods

Setting and written report population

From February 2005 to July 2010 in the emergency department of the fifth people's hospital of Shanghai, 293 suspected astute exacerbation of asthma patients were screened for eligibility to participate in this study. Of these, 265 patients meeting the Bronchial Asthma Guide were eligible and 255 patients completed the study, including 123 male patients and 132 female patients. Patients were eligible for the intervention if they met all the following criteria: 1) ≥ 18 years onetime; 2) has whatever, or all, of the following clinical features as defined by the Global Initiative for National Asthma (GINA) Guidelines: dyspnea, wheeze, acute cough, increased work of breathing, increased requirement for beta2-agonist from baseline employ, O2 saturation <95%, a meridian expiratory menstruum (PEF) at randomization ≤80% of their known all-time (inside the last 12 months) or, in the absence of this data, of their predicted PEF [1]. The exclusion criteria in the study are: i) handling with antibiotics inside ii weeks just before the recruitment; 2) bacterial infection in other parts of body than the respiratory system; 3) chest X-ray confirmed pneumonia; four) suffering from other chronic respiratory diseases; v) suffering from severe organ dysfunction. The protocol was canonical by the Ethics Commission of the Fudan University. Written informed consent was obtained from all patients or their legally authorized representative.

Experimental protocol

Nosotros conducted a randomized, controlled trial. All eligible patients were assigned to either the Percentage-guided antibiotics therapy group or the control grouping, in which the attending physicians decide the utilise of antibiotics according to usual practise. The flowchart of patients was summarized in Effigy 1. Allocation to either intervention was conducted according to estimator-generated random numbers produced by an independent statistician. Later randomization, an opaque, sealed and sequentially numbered envelope containing the Percentage or control protocol was prepared for each field of study according to the group. All patients received similar conventional treatment, such as the repetitive administration of rapid-acting inhaled bronchodilator, introduction of systemic glucocorticosteroids and oxygen supplementation. Procalcitonin levels of patients in the Pct group were notified to the attending doc in charge of this grouping. Patients in the Percentage grouping were treated with antibiotics according to their PCT serum level according the following guidelines: antibiotics treatment was strongly discouraged when serum Pct level was less than 0.1 μg/L; antibiotics handling was discouraged when serum Percent level was less than 0.25 μg/Fifty; antibiotics treatment was encouraged when serum Per centum level was greater than 0.25 μg/L [11]. In contrast, attending physicians responsible for patients in the command group remained unaware of the patients' procalcitonin concentrations throughout the report. The control grouping received antibiotics according to the attending physicians' determination. The patients with Percentage < 0.25 ng/ml in the get-go Per centum exam would take the Pct test over again after six to eight hours. The apply of antibiotics would be determined by the second PCT test result.

Effigy i
figure 1

Patient flow chart.

Full size image

We appointed an independent investigator squad blinded to the grouping consignment to monitor the adherence to the protocol, the safety and efficacy of the intervention, as well as chief and secondary outcomes during the six-calendar week follow-up period. All patients, laboratory technicians, investigators and research designers were blinded to patient assignments until the data analysis was completed. There were no protocol violations during the written report.

Outcome measures

Our chief endpoint was the use of antibiotics, which was evaluted past the antibiotic prescription charge per unit and the relative adventure of antibiotic exposure in patients with acute exacerbations of asthma. The secondary endpoints were patients' clinical, laboratory, and lung office outcomes at the follow-upwards visit (6 weeks). During the six-calendar week follow-upwardly period, secondary ED visits, hospital re-admissions, repeated needs for steroids or dosage increment, needs for antibiotics, white blood jail cell count (WBC), PCT levels and FEV1% were assessed.

Data collection

The serum PCT tests were done using a time-resolved amplified cryptate emission (TRACE) technology assay (Kryptor® PCT, Brahms AG, Hennigsdorf, Deutschland) with a functional assay sensitivity of 0.06 chiliad/50, about four-fold in a higher place the mean normal PCT level. And several laboratory parameters of the patients, including the levels of high sensitivity C-reactive protein (hsCRP), interleukin six (IL-half dozen), and tumor necrosis gene α (TNF-α), as well as WBC, were measured and collected. Arterial blood gas analysis was likewise performed on all patients. The usage of antibiotics in 2 groups was recorded. Forced expiratory volume in one 2nd (FEV1) was collected before and later on treatment. The symptom scores of asthma were likewise recorded. The patients were categorized into mild, moderate, and severe subgroups based on the severity level of their asthma, according to which antibiotics utilize was analyzed. The patients were re-categorized during the six-week follow-up menses to assess the asthma command.

Statistical analysis

We assumed that 75% of the patients in the control group would utilise antibiotics and anticipated a 20% decrease in antibiotics usage in the PCT group. The current sample size of 128 patients in the PCT group and 127 in the command group yielded a ability of 0.96 to detect difference in usage of antibiotics at 1-sided 5% significance level. Moreover, the power was 1.00 for non-inferiority testing on asthma control at a significance level of 2-sided 0.05, "controlled" percentage of 75% in both Percent and control groups and a non-inferiority limit (d) of 65%.

Discrete variables are expressed every bit counts (percentages) and continuous variables as mean ± SD. Comparability of groups was analyzed past χ2 examination, two-sampled t test, Mann–Whitney U test, as advisable. Correlation analyses of the level of serum PCT and levels of hsCRP, IL-vi, TNF-α and WBC were performed using Spearman rank. A p value less than 0.05 was defined every bit significant. Data were analyzed using statistical software (Statistical Parcel for Social Sciences, version 14 for Windows; SPSS; Chicago IL).

Results

The patients were aged betwixt nineteen and 78 years former and the average age was 53 ± 15 years old. Detailed baseline characteristics of the studied population are presented in Table 1.

Table ane Baseline characteristics of the two groups

Full size table

The FEV1 score of both groups was significantly improved after handling compared with that before treatment. Xxx-2 (25.0%) patients in PCT group received corticosteroids therapy, while 36 (28.three%) patients received corticosteroids therapy in the control grouping (χ 2 = 0.thirteen, p = 0.714). Eight (6.three%) patients in Percentage grouping and nine (seven.ane%) patients in the control group (χ 2 = 0.05, p = 0.821) received mechanical ventilation handling.

Table 2 showed the details of the levels of inflammatory parameters in patients. The patients with severe-disquisitional asthma had higher serum PCT levels and IL-6 levels compared with those with balmy-moderate asthma (p < 0.05). Other inflammatory parameters that we tested showed no pregnant difference between patients with mild-moderate asthma and severe-critical asthma. Spearman assay showed that the serum PCT level didn't correlate with the level of whatever laboratory biomarkers except for IL-6 (r = 0.705, p = 0.003).

Table 2 Comparison of inflammatory variables

Total size tabular array

As shown in Tabular array 3, only 46.1% of the patients in Percent grouping received antibiotics therapy, which was much lower compared with 74.8% in the control group (χtwo = 21.97, p = 0.000, RR = 0.561, 95% CI 0.441-0.713). Table 3 also showed that the usage of antibiotics in the PCT group patients with mild and moderate asthma were significantly lower than that in the control group (p <0.01). There was no significant statistical difference in the usage of antibiotics betwixt patients with severe and critical asthma in the ii groups.

Tabular array 3 Comparison of the usage of antibiotics

Full size table

The asthma control categorized to three levels was comparable between two groups during the six-calendar week follow-up period (χii =1.62, p = 0.45) (Table iv). In that location were no pregnant departure regarding other secondary outcomes such as secondary ED visits, infirmary re-admissions, repeated needs for steroids or dosage increase, needs for antibiotics, WBC, PCT levels and FEV1% between two groups (p > 0.05).

Table 4 Comparison of the levels of asthma control and the follow-up outcomes between two groups

Full size table

Word

This study showed that Percent test could help physicians to determine whether patients were suffering from respiratory tract bacterial infections. As a result, Percentage exam increases the safety level of the treatment strategies of acute exacerbations of asthma via avoiding antibiotics corruption. The study published by Briel et al. was non particularly convincing since merely nine asthma patients were included [9]. Thus far this is the only clinical written report focusing on evaluating the Percent exam in its effectiveness to guide antibiotics usage in treating acute exacerbations of asthma.

Per centum, a protein of 116 amino acids with a molecular weight of xiii kDa, was discovered 25 years agone equally a prohormone of calcitonin produced by C-cells of the thyroid gland [16]. Under normal physiological conditions, Pct is stable in human torso [17]. PCT is intracellularly broken by proteolytic enzymes to generate the active hormone. Circulating levels of PCT in good for you subjects are below detection limit. Information technology was constitute in 1993 that the serum Pct level is elevated in patients with bacterial infection [xviii]. Since then PCT has become an important protein in the detection and differential diagnostics of inflammatory states [3–5]. In microbial infections and in various forms of inflammation, circulating levels of Per centum increase to several thousand-fold of its normal level [eighteen, 19]. In this example, PCT is produced past other tissues, especially adherent monocytes and macrophage-activated adipocytes [xix]. This increase correlates significantly with the severity of the status and with mortality. However, Pct level does not increase markedly in patients with autoimmune inflammation or virus infection [three–5, 7]. PCT is released inside iv hours in the initial stages of infection, and peaks in eight hours. Then Per centum level begins to decrease when the infection is under control. The half-life of PCT is betwixt 20 and 24 hours [17, 20]. The serum PCT level is interfered past hormone levels and can easily be detected in a short fourth dimension [21]. Small doses of intravenous lipid polysaccharide in salubrious volunteers could induce the product of PCT [21]. The serum PCT tin be detected later two hours and the Per centum level increased rapidly in the following six to eight hours [21]. The PCT level reaches the acme l2 to 48 hours later and returns to normal in two to 3 days [22]. Respiratory tract infections induce the acute attacks of asthma. Bacterial infection seems to but play a minor role in acute exacerbations of asthma, while virus infection plays a major role [one, 23, 24]. So many patients with acute asthma don't demand antibiotics. Antibiotic therapy benefits those patients with bacterial infection by alleviating respiratory tract spasm and shortening the duration of acute exacerbation, while it harms patients without bacterial infection by worsening their condition and increasing the take chances of selective bacterial resistance [2, 23]. The physicians often determine whether patients suffer from respiratory tract bacterial infections on the footing of sputum characteristics, body temperature, WBC, CRP and other indicators. However, clinical signs and symptoms of bacterial infection and other non-bacterial infections are often indistinguishable, making it difficult for physicians to decide accurately in clinical practice whether there is a bacterial infection in respiratory tract of patients [25]. In full general, bacterial culture is much authentic for diagnosis. Notwithstanding, bacterial culture takes too long time and it is difficult to obtain accurate information on etiology from asthma patients. Therefore bacterial civilization is not suitable for the emergent treatment of asthma. And the positive rate of bacterial culture was express by the hospital medical standards, medical technicians operating experience and other factors, which makes bacterial culture a less constructive measure. When there is no constructive approach for physicians to make up one's mind accurately whether there is a bacterial infection, physicians are more likely to employ antibiotic therapy for most acute asthma patients, leading to antibiotics corruption and subsequent bacterial resistance [2]. Recent studies showed that serum PCT level has higher sensitivity in determining whether bacterial infection exist in community caused pneumonia, ventilator associated pneumonia and astute exacerbation of chronic obstructive pulmonary disease and can guide the usage of antibiotics [6, 8, 26]. The serum Pct level is also an early diagnostic index and tin can identify sepsis from systemic inflammatory response syndrome (SIRS) [3, 7, 14]. Percentage test can objectively determine the severity of sepsis and be closely related to the severity of multiple organ dysfunction syndrome (MODS) [3, 7, 14]. Physicians can judge the direction of progression and evaluate the therapeutic effectiveness by continuously monitoring the serum Percentage level [27, 28].

In this written report, nosotros treated the patients with antibiotics according to PCT serum level. Antibiotics usage was strongly discouraged when the serum Pct concentration was below 0.ane μg/L; antibiotics usage was discouraged when the serum PCT concentration was between 0.1 μg/L and 0.25 μg/L; and antibiotics usage was encouraged when the serum Per centum concentration was greater than 0.25 μg/L. The results showed that many patients in the Per centum group did not need antibiotics. The antibiotic usage rate was lower than that of the control grouping and the issue of treatment was not significantly affected, especially for patients with mild to moderate asthma. Patients with mild to moderate asthma in the control grouping did not need antibiotics, which implicated that PCT could play an of import function in guiding the use of antibiotics. Although at that place was no significant statistical divergence in the rate of antibiotics usage in patients with astringent to disquisitional asthma between the two groups, the trend of antibiotics usage in PCT group deceased in comparing with the control group. Appropriately, we believe that Pct is a serum marker for the advisable selection of antibiotics in the handling of acute attack of asthma. Percentage can be quickly tested to assist determine whether there is bacterial infection and whether antibiotics are needed for the emergency treatment of patients.

In this study, the serum Percentage level and IL-6 level were correlated, while there is no correlation between the serum PCT level and levels of other inflammatory indicators, including hsCRP, TNF-α, and WBC. Cellular IL-6 level rises sharply subsequently exposure to bacterial toxins, falls rapidly as time elapses and has a longer one-half-life than TNF-α [29, 30]. As a critical mediator of survival following pulmonary infection and sepsis, it protects patients from death by augmenting neutrophil killing of bacteria, enhancing the release of adrenaline and cortisol, too as selectively activating the coagulation system [31, 32]. IL-half-dozen has the best discriminative power in sepsis and non-infectious SIRS, with sensitivity above 80% and specificity higher up lxx%, which is higher than conventional inflammatory markers including CRP and TNF-α [33]. In that location are limitations in the sensitivity and specificity of hsCRP, TNF-α, and WBC in judging whether patients with asthma are also suffering from bacterial infection. Both Pct and IL-six levels of patients with severe to critical asthma in the PCT group were higher than that of patients with balmy to moderate asthma in the same group. It implicated that patients with severe to critical asthma may exist more than prone to bacterial infection than patients with balmy to moderate asthma. Zhang et al. found that bacterial colonization of the lower airways was common in patients with chronic severe asthma and was linked to the elapsing of asthma and the exacerbations in past years [34, 35]. Therefore, PCT examination prevents antibiotics usage by and large in patients with mild to moderate asthma simply without bacterial infection, while most patients with severe to disquisitional asthma do suffer from bacterial infection and need to be treated with proper antibiotics.

Conclusion

In summary, this written report showed the Percentage exam tin can exist used accurately and effectively to determine whether the acute asthma patients have bacterial infections in respiratory tract, and to guide the use of antibiotics in the treatment of acute asthma. So PCT test has great value in reducing unnecessary antibiotics use and in preventing the occurrences of antibiotics resistance in the treatment of acute asthma, particularly in countries where patients are suffering from the abuse of antibiotics. Our written report has several limitations. Starting time, we included a relatively small number of patients. However, for the 128 patients in Pct group and 127 in command grouping, the power reached 0.99 with 1-sided v% significance level to detect the difference in usage of antibiotics and was 0.88 for non-inferiority testing with a non-inferiority limit (d) of 65% on asthma control. 2nd, our results should not be generalized to other settings such as infirmary-caused pneumonia and chronic obstructive pulmonary disease. Third, we did not conduct a formal cost-benefit study. Larger clinical trials are needed to explore the overall clinical and economic affect of the reduction of exposure to antibiotics in asthma patients.

Authors' data

Co-showtime writer Wei Long.

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Acknowledgements

The study was sponsored by a grant from the Shanghai 5th People's Hospital Science Foundation (09YRCPY11) AND Minhang District Natural Science Foundation of Shanghai (10MHWSJ11).

The authors thank Wanghong Xu (Acquaintance professor, Department of Epidemiology School of Public Health, Fudan University) for statistical guidance.

Author data

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    Affiliations

    1. Department of Trauma-Emergency & Disquisitional Care Medicine, Shanghai Fifth People'south Hospital, Fudan Academy, Shanghai, 200240, P.R. China

      Jianguo Tang, Lei Yan, Yu Zhang, Gang Lu & Chunhui Yang

    2. Department of Geriatrics, Shanghai Sixth People's Hospital, Jiaotong University, Shanghai, 200233, P.R. China

      Wei Long

    3. Department of Pulmonary Medicine, Shanghai Fifth People's Hospital, Fudan University, Shanghai, 200240, P.R. People's republic of china

      Juan Xie

    Respective author

    Correspondence to Jianguo Tang.

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    Competing interests

    The authors declare that they accept no competing interests.

    Authors' contributions

    LW carried out the investigation, participated in study design and drafted the manuscript. YL and ZY carried out the investigation, participated in the laboratory measuring. XJ participated in the study design, carried out the investigation. LG participated in the pattern of the study and performed the statistical assay. YCH carried out the investigation, participated in the laboratory measuring. TJG conceived the idea of the study, and participated in its pattern and coordination and helped to draft the manuscript. All authors read and canonical the final manuscript.

    Jianguo Tang, Wei Long contributed equally to this work.

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    Tang, J., Long, W., Yan, L. et al. Procalcitonin guided antibiotic therapy of astute exacerbations of asthma: a randomized controlled trial. BMC Infect Dis xiii, 596 (2013). https://doi.org/ten.1186/1471-2334-13-596

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    • DOI : https://doi.org/10.1186/1471-2334-xiii-596

    Keywords

    • Asthma
    • Procalcitonin
    • Antibiotic

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