Anerning Granule for Community Acquired Pneumonia: Protocol for Randomized, Double-Blind, Single-Dummy, Parallel Control of Placebo, Multicenter Clinical Trial

Background: Community acquired pneumonia (CAP) in children is one of the common clinical diseases and infectious diseases threatening the health of the population. CAP has complicated causes, closely related to region, season, age, and primary disease. It is the most common cause of children being hospitalized and the first cause of death for children under 5 years old. At present, the clinical treatment is mainly antibiotics, but abuse and non-standard combination of antibiotics have led to increasing antibiotic resistance. Anerning Granules have the functions of clearing away heat and removing wind, reducing phlegm and relieving cough, and improving cough symptoms and lung signs. Thus, this study aims to evaluate the efficacy and safety of Anerning Granules (AEN) in the treatment of community-acquired pneumonia in children, and to explore whether AEN can reduce the use of antibiotics and have a good effect on the clinical treatment of CAP.Methods and analysis: this study, a randomized, double-blind, single-dummy, parallel control of placebo, multicenter clinical study will be established in 7 hospitals in the same period. A total of 216 patients with community-acquired pneumonia will be randomly allocated at a ratio of 2:1 to two groups: experimental group, control group. The experimental group receives Anerning Granules plus ceftriaxone sodium; the control group receives AEN placebo plus ceftriaxone sodium. Each group will be treated for ten days, and a stage effect evaluation will be conducted on the sixth day. The primary outcome is the end of antibiotics in frequency (DDDs) and effective rate. Secondary outcome measures of effectiveness are the full fever time, sore throat onset time, and safety assessment. Outcomes will be assessed at baseline and after treatment. In addition, adverse events will be monitored throughout the trial process and must be traced to be resolved.Discussion: This study protocol will provide the research data regarding the efficacy and safety of AEN for the treatment of community-acquired pneumonia in children. The first aim is to determine whether Anerning Granules can reduce the use of antibiotics; the second aim is to evaluate the effectiveness of Anerning Granules combined with ceftriaxone sodium in the treatment of children with community-acquired pneumonia. The third aim is to observe the safety of clinical application of Anerning Granules. The results of this study will improve the rational use of drugs, especially the rational application of antibiotics. It will also enable safety evaluation from laboratory indices of adverse events, which will provide reliable evidence for clinical treatment.Trial registration: Clinicaltrials.gov identifier: NCT03675178, registered on 16 September 2018.