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Safety of azithromycin in pediatrics: a systematic review and meta-analysis.

ABSTRACT: PURPOSE:To evaluate the toxicity of azithromycin in neonates, infants, and children. METHODS:A systematic review was performed for relevant studies using Medline (Ovid), PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, and International Pharmaceutical Abstracts. We calculated the pooled incidence of adverse drug reactions (ADRs) associated with azithromycin based on prospective studies (RCTs and prospective cohort studies) and analyzed the risk difference (RD) of ADRs between azithromycin and placebo or other antibiotics using meta-analysis of RCTs. RESULTS:We included 133 studies with 4243 ADRs reported in 197,675 neonates, infants, and children who received azithromycin. The safety of azithromycin as MDA in pediatrics was poorly monitored. The main ADRs were diarrhea and vomiting. In prospective non-MDA studies, the most common toxicity was gastrointestinal ADRs (938/1967; 47.7%). The most serious toxicities were cardiac (prolonged QT or irregular heart beat) and idiopathic hypertrophic pyloric stenosis (IHPS). Compared with placebo, azithromycin did not show increased risk ADRs based on RCTs (risk difference -?0.17 to 0.07). The incidence of QT prolonged was higher in the medium-dosage group (10-30 mg/kg/day) than that of low-dosage group (??10 mg/kg/day) (82.0% vs 1.2%). CONCLUSION:The safety of azithromycin as MDA needs further evaluation. The most common ADRs are diarrhea and vomiting. The risk of the most serious uncommon ADRs (cardiac-prolonged QT and IHPS) is unknown.

SUBMITTER: Zeng L

PROVIDER: S-EPMC7661415 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Safety of azithromycin in pediatrics: a systematic review and meta-analysis.

Zeng Linan L Xu Peipei P Choonara Imti I Bo Zhenyan Z Pan Xiangchen X Li Wenyan W Ni Xiaofeng X Xiong Tao T Chen Can C Huang Leshan L Qazi Shamim Ahmad SA Mu Dezhi D Zhang Lingli L

European journal of clinical pharmacology 20200717 12

<h4>Purpose</h4>To evaluate the toxicity of azithromycin in neonates, infants, and children.<h4>Methods</h4>A systematic review was performed for relevant studies using Medline (Ovid), PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, and International Pharmaceutical Abstracts. We calculated the pooled incidence of adverse drug reactions (ADRs) associated with azithromycin based on prospective studies (RCTs and prospective cohort studies) and analyzed the risk difference (R ...[more]

PMID: 32681202

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Project description:BackgroundMalaria is a major cause of morbidity and mortality in pediatrics in malaria endemic areas. Artemisinin-based combination therapies (ACTs) are the drugs of choice for malaria management particularly across malaria-endemic countries. This systematic review and meta-analysis was performed to assess efficacy and safety of ACTs for uncomplicated malaria in pediatric populations.MethodsA body of evidence was searched for published ACT trials until March 06, 2020. The search was focused on efficacy and safety studies of ACTs for uncomplicated malaria in pediatrics. PubMed library was searched using best adapted search terms after multiple trials. References were exported to the endnote library and then to Covidence for screening. Data was extracted using the Covidence platform. The per-protocol analysis report for the efficacy and the intention-to-treat analysis for the safety were synthesized. Met-analysis was carried using Open Meta-Analyst software. Random effects model was applied and the heterogeneity of studies was evaluated using I2 statistic.ResultsNineteen studies were included in the final analysis. Overall, crude, PCR-corrected P. falciparum malaria treatment success rate was 96.3 and 93.9% for day 28 and 42, respectively. In the subgroup analysis, PCR-corrected adequate clinical and parasitological response (ACPR) of dihydroartemisinin-piperaquine (DP) was 99.6% (95% CI: 99.1 to 100%, I2 = 0%; 4 studies) at day 28 and 99.6% (95% CI of 99 to 100%, I2 = 0%; 3 studies) at day 42. Nine studies reported ACT related adverse drug reactions (ADR) (8.3%, 356/4304). The reported drug related adverse reactions ranged from 1.8% in DP (two studies) to 23.3% in artesunate-pyronaridine (AP). Gastrointestinal symptoms were the most common ACT related adverse effects, and all ADRs were reported to resolve spontaneously.ConclusionACTs demonstrated a high crude efficacy and tolerability against P. falciparum. The high treatment success and tolerability with low heterogeneity conferred by DP has implication for policy makers who plan the use of ACTs for uncomplicated falciparum malaria treatment in pediatrics.

Project description:Introduction HIV-positive status disclosure for children is challenging for family members, guardians, and healthcare professionals. Disclosure is very challenging, particularly for children, yet no systematic synthesis of evidence accurately measures HIV-positive status disclosure in children. This systematic review and meta-analysis study aimed to quantify the national prevalence of pediatric HIV-positive status disclosure in Ethiopia and identify factors associated with HIV-positive status disclosure. Method We systematically searched PubMed, EMBASE, Web of Science databases, and google scholar for relevant published studies. Studies published in the English language and conducted with cohort, case-control, and cross-sectional designs were eligible for the review. The primary and secondary outcomes of the study were HIV-positive status disclosure and factors associated with HIV-positive status disclosure, respectively. The quality of the included studies was assessed using the Joanna Briggs Institute critical appraisal tools. A random effect- model was used to estimate the pooled prevalence of HIV-positive status disclosure. Heterogeneity and publication bias of included studies was determined using I2 and Egger’s test, respectively. Result From 601 records screened, nine relevant studies consisting of 2,442 HIV-positive children were included in the analysis. The overall pooled prevalence of HIV-positive status disclosure among children living with HIV/AIDS in Ethiopia was 31.2% (95% CI [23.9–38.5]). HIV-negative status of caregivers (AOR: 2.01; 95% CI [1.28–3.18]), long duration on ART (greater than 5 years) (AOR: 3.2; 95% CI [1.77–5.78]) and older age of the child (>10 years) (AOR: 7.2; 95% CI [4.37–11.88]) were significantly associated with HIV-positive status disclosure. Conclusion Low prevalence of pediatric HIV-positive status disclosure was observed in Ethiopia. The longer duration of ART, the HIV-negative status of the caregiver, and older age greater than 10 years were the predictors of pediatric HIV-positive status disclosure. Health system leaders and policymakers shall design training and counseling programs for healthcare professionals and caregivers to enhance their awareness about HIV-positive status disclosure. Trial registration This review was registered under PROSPERO and received a unique registration number, CRD42019119049.

Dataset Information

Safety of azithromycin in pediatrics: a systematic review and meta-analysis.

Publications

Safety of azithromycin in pediatrics: a systematic review and meta-analysis.

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