Azithromycin to Prevent Sepsis or Death in Women Planning a Vaginal Birth

Tita, Alan T.N.; Carlo, Waldemar A.; McClure, Elizabeth M.; Mwenechanya, Musaku; Chomba, Elwyn; Hemingway-Foday, Jennifer; Kavi, Avinash; Metgud, Mrityunjay C; Goudar, Shivaprasad S; Derman, Richard; Lokangaka, Adrien; Tshefu, Antoinette; Bauserman, Melissa; Bose, Carl; Shivkumar, Poonam Varma; Waikar, Manju; Patel, Archana; Hibberd, Patricia L.; Nyongesa, Paul; Esamai, Fabian; Ekhaguere, Osayame A.; Bucher, Sherri; Jessani, Saleem; Tikmani, Shiyam Sunder; Saleem, Sarah; Goldenberg, Robert L.; Billah, Sk M; Lennox, Ruth; Haque, Rashidul; Petri, William A.; Figueroa, Lester; Mazariegos, Manolo; Krebs, Nancy F.; Moore, Janet; Nolen, Tracy L.; Koso‐Thomas, Marion

doi:10.1056/nejmoa2212111

Cited by 35 publications

(63 citation statements)

References 23 publications

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“…The rate was 1.1% in the azithromycin group and 1.7% in the placebo group (RR 0.66, 95% CI 0.56-0.77; Figure 3; evidence certainty high; Table 2). Five studies [5][6][7]11,12 analysed mortality rates and did not show evidence of a difference (0.09% versus 0.08%; RR 1.26, 95% CI 0.65-2.42; Figure 3). Evidence certainty was ranked as moderate (Table 2).…”

Section: Maternal Outcomesmentioning

confidence: 98%

“…Initially, we assessed 410 abstracts: 13 full reports were further evaluated, and finally 5 studies included. [5][6][7]11,12 (Figure 1) All of the included studies were double-blinded and placebo-controlled (Table 1). Azithromycin dose varied between 500 mg and 2 g, and four studies gave it orally and one intravenously.…”

Section: R E Su Ltsmentioning

confidence: 99%

“…Wound infection (3 studies, 5,7,12 31 728 parturients) rate was lower in the azithromycin group (1.6%) than in the placebo group (2.5%) (RR 0.52 (95% CI 0.30-0.89; Figure 3); evidence certainty was ranked as moderate (Table 2). The maternal sepsis rate was assessed in five studies [5][6][7]11,12 (44 190 parturients). The rate was 1.1% in the azithromycin group and 1.7% in the placebo group (RR 0.66, 95% CI 0.56-0.77; Figure 3; evidence certainty high; Table 2).…”

Section: Maternal Outcomesmentioning

confidence: 99%

“…sensitivity analysis analysed the impact of an individual study on pooled effect estimate), the dropping of the largest trial 12 changed the estimate of maternal sepsis to RR 0.75 (95% CI 0.46-1.23) and thus the finding was now imprecise. Other maternal estimates remained nearly unchanged (Figure S3).…”

Section: Maternal Outcomesmentioning

confidence: 99%

“…5,7 However, two large-scale randomised controlled trials were recently published which analysed both mothers and neonates and found benefits for mothers but not for neonates. 11,12 These were both conducted in low-income settings. Although the previous studies have been large, they have still been underpowered to estimate maternal mortality, and thus a systematic review with meta-analysis could have the power to detect possible effects.…”

Section: Introductionmentioning

confidence: 99%

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Intrapartum azithromycin to prevent maternal and neonatal sepsis and deaths: A systematic review with meta‐analysis

Kuitunen,

Kekki,

Renko

2023

BJOG

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ObjectivesA systematic review with met‐analysis was performed to summarise the evidence on the effect of intrapartum azithromycin on maternal and neonatal infections and deaths.Search strategyPubMed, Scopus and Web of Science databases were searched in March 2023.Selection criteriaRandomised controlled trials comparing intrapartum single‐dose of azithromycin with placebo.Data collection and analysisMaternal infections, maternal mortality, neonatal sepsis, neonatal mortality. We used the random‐effects Mantel–Haenszel method to calculate risk ratios (RR) with 95% confidence intervals (95% CI). We assessed risk of bias of the included studies and estimated the evidence certainty using the GRADE approach.Main resultsAfter screening 410 abstracts, five studies with 44 190 women and 44 565 neonates were included. The risk of bias was low in four and had some concerns in one of the studies. The risk of endometritis was 1.5% in the azithromycin group and 2.3% in the placebo group (RR 0.64, 95% CI 0.55–0.75), and the evidence certainty was high. The respective risk for chorioamnionitis was 0.05% and 0.1% (RR 0.50, 95% CI 0.22–1.18; evidence certainty moderate). The wound infection rate was lower in the azithromycin group (1.6%) than in the placebo group (2.5%), RR 0.52 (95% CI 0.30–0.89; moderate certainty evidence). The maternal sepsis rate was 1.1% in the azithromycin group and 1.7% in the placebo group (RR 0.66, 95% CI 0.56–0.77; evidence certainty high). Mortality rates did not show evidence of a difference (0.09% versus 0.08%; RR 1.26, 95% CI 0.65–2.42; moderate certainty evidence). The neonatal mortality rate was 0.7% in the azithromycin group and 0.8% in the placebo group (RR 0.94, 95% CI 0.76–1.16; moderate certainty evidence). The neonatal sepsis rate was 7.6% in the azithromycin group and 7.4% in the placebo group (RR 1.02, 95% CI 0.96–1.09; moderate certainty evidence).ConclusionsIntrapartum administration of azithromycin to the mother reduces maternal postpartum infections, including sepsis. Impact on maternal mortality remains undecided. Azithromycin does not reduce neonatal sepsis or mortality rates.

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Section: Maternal Outcomesmentioning

confidence: 98%

Section: R E Su Ltsmentioning

confidence: 99%

Section: Maternal Outcomesmentioning

confidence: 99%

Section: Maternal Outcomesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Intrapartum azithromycin to prevent maternal and neonatal sepsis and deaths: A systematic review with meta‐analysis

Kuitunen,

Kekki,

Renko

2023

BJOG

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Mass Azithromycin Distribution to Prevent Child Mortality in Burkina Faso

Oldenburg,

Ouattara,

Bountogo

et al. 2024

JAMA

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ImportanceRepeated mass distribution of azithromycin has been shown to reduce childhood mortality by 14% in sub-Saharan Africa. However, the estimated effect varied by location, suggesting that the intervention may not be effective in different geographical areas, time periods, or conditions.ObjectiveTo evaluate the efficacy of twice-yearly azithromycin to reduce mortality in children in the presence of seasonal malaria chemoprevention.Design, Setting, and ParticipantsThis cluster randomized placebo-controlled trial evaluating the efficacy of single-dose azithromycin for prevention of all-cause childhood mortality included 341 communities in the Nouna district in rural northwestern Burkina Faso. Participants were children aged 1 to 59 months living in the study communities.InterventionsCommunities were randomized in a 1:1 ratio to receive oral azithromycin or placebo distribution. Children aged 1 to 59 months were offered single-dose treatment twice yearly for 3 years (6 distributions) from August 2019 to February 2023.Main Outcomes and MeasuresThe primary outcome was all-cause childhood mortality, measured during a twice-yearly enumerative census.ResultsA total of 34 399 children (mean [SD] age, 25.2 [18] months) in the azithromycin group and 33 847 children (mean [SD] age, 25.6 [18] months) in the placebo group were included. A mean (SD) of 90.1% (16.0%) of the censused children received the scheduled study drug in the azithromycin group and 89.8% (17.1%) received the scheduled study drug in the placebo group. In the azithromycin group, 498 deaths were recorded over 60 592 person-years (8.2 deaths/1000 person-years). In the placebo group, 588 deaths were recorded over 58 547 person-years (10.0 deaths/1000 person-years). The incidence rate ratio for mortality was 0.82 (95% CI, 0.67-1.02; P = .07) in the azithromycin group compared with the placebo group. The incidence rate ratio was 0.99 (95% CI, 0.72-1.36) in those aged 1 to 11 months, 0.92 (95% CI, 0.67-1.27) in those aged 12 to 23 months, and 0.73 (95% CI, 0.57-0.94) in those aged 24 to 59 months.Conclusions and RelevanceMortality in children (aged 1-59 months) was lower with biannual mass azithromycin distribution in a setting in which seasonal malaria chemoprevention was also being distributed, but the difference was not statistically significant. The study may have been underpowered to detect a clinically relevant difference.Trial RegistrationClinicalTrials.gov Identifier: NCT03676764

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Single‐dose oral azithromycin prophylaxis in planned vaginal delivery for sepsis prevention: A systematic review and meta‐analysis of randomized controlled trials

Crosara,

Orsini,

Eskandar

et al. 2023

Intl J Gynecology & Obste

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IntroductionThe use of oral azithromycin (AZI) as a preventive measure against postpartum infections of planned vaginal births has garnered a lot of interest in recent years and has been the subject of many randomized controlled trials (RCTs). However, the results from these trials have not been consistent. Therefore, we aim to perform a systematic review and meta‐analysis to determine whether the use of a single‐dose of oral AZI is clinically significant.MethodsWe systematically searched PubMed, Embase, and Cochrane Central for RCTs from May to June 2023, comparing a single dose of oral AZI with placebo in patients undergoing planned vaginal delivery at a minimum of 28 weeks of gestational age. The main outcomes were puerperal and neonatal sepsis. Statistical analyses were performed using Review Manager 5.4.1 (Cochrane Collaboration). Heterogeneity was assessed with I2 statistics.ResultsFour RCTs were included (mothers, n = 42 235; newborns n = 42 492). Approximately 49.8% of mothers received a single dose of oral AZI for sepsis prophylaxis. Compared with placebo, AZI significantly reduced the incidence of puerperal sepsis (risk ratio [RR], 0.65 [95% confidence interval (CI), 0.55–0.77]; P < 0.001), mastitis or breast abscess (RR, 0.58 [95% CI, 0.42–0.79]; P < 0.001), endometritis (RR, 0.65 [95% CI, 0.54–0.77]; P < 0.001), wound infection (RR, 0.81 [95% CI, 0.69–0.96]; P = 0.013), infection rate (RR, 0.62 [95% CI, 0.51–0.76]; P < 0.001), and fever (RR, 0.50 [95% CI, 0.28–0.89]; P = 0.018) in mothers. No statistically significant differences were identified between groups regarding maternal all‐cause mortality and the use of prescribed postpartum antibiotics. Similarly, no statistical differences were noted in the neonatal group regarding sepsis, infection rate, and all‐cause mortality.ConclusionAZI appears to be an effective preventive measure against many postpartum infections in mothers but a substantial impact on neonatal outcomes has not yet been conclusively observed.

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Azithromycin to Prevent Sepsis or Death in Women Planning a Vaginal Birth

Cited by 35 publications

References 23 publications

Intrapartum azithromycin to prevent maternal and neonatal sepsis and deaths: A systematic review with meta‐analysis

Intrapartum azithromycin to prevent maternal and neonatal sepsis and deaths: A systematic review with meta‐analysis

Mass Azithromycin Distribution to Prevent Child Mortality in Burkina Faso

Single‐dose oral azithromycin prophylaxis in planned vaginal delivery for sepsis prevention: A systematic review and meta‐analysis of randomized controlled trials

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