Francis I Proctor Foundation, University of California, San Francisco, 490 Illinois Street, Floor 2, San Francisco, CA, 94158, USA.
Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.
BMC Infect Dis. 2022 Mar 25;22(1):285. doi: 10.1186/s12879-022-07296-4.
Azithromycin is a broad-spectrum antibiotic that has moderate antimalarial activity and has been shown to reduce all-cause mortality when biannually administered to children under five in high mortality settings in sub-Saharan Africa. One potential mechanism for this observed reduction in mortality is via a reduction in malaria transmission.
We evaluated whether a single oral dose of azithromycin reduces malaria positivity by rapid diagnostic test (RDT). We conducted an individually randomized placebo-controlled trial in Burkina Faso during the high malaria transmission season in August 2020. Children aged 8 days to 59 months old were randomized to a single oral dose of azithromycin (20 mg/kg) or matching placebo. At baseline and 14 days following treatment, we administered a rapid diagnostic test (RDT) to detect Plasmodium falciparum and measured tympanic temperature for all children. Caregiver-reported adverse events and clinic visits were recorded at the day 14 visit.
We enrolled 449 children with 221 randomized to azithromycin and 228 to placebo. The median age was 32 months and 48% were female. A total of 8% of children had a positive RDT for malaria at baseline and 11% had a fever (tympanic temperature ≥ 37.5 °C). In the azithromycin arm, 8% of children had a positive RDT for malaria at 14 days compared to 7% in the placebo arm (P = 0.65). Fifteen percent of children in the azithromycin arm had a fever ≥ 37.5 °C compared to 21% in the placebo arm (P = 0.12). Caregivers of children in the azithromycin group had lower odds of reporting fever as an adverse event compared to children in the placebo group (OR 0.41, 95% CI 0.18-0.96, P = 0.04). Caregiver-reported clinic visits were uncommon, and there were no observed differences between arms (P = 0.32).
We did not find evidence that a single oral dose of azithromycin reduced malaria positivity during the high transmission season. Caregiver-reported fever occurred less often in children receiving azithromycin compared to placebo, indicating that azithromycin may have some effect on non-malarial infections. Trial registration Clinicaltrials.gov NCT04315272, registered 19/03/2020.
阿奇霉素是一种广谱抗生素，具有中等的抗疟活性，已被证明可降低撒哈拉以南非洲高死亡率地区五岁以下儿童每年两次服用阿奇霉素的全因死亡率。这种观察到的死亡率降低的一个潜在机制是通过降低疟疾传播。
我们评估了单次口服阿奇霉素是否会通过快速诊断检测 (RDT) 降低疟疾阳性率。我们在 2020 年 8 月高疟疾传播季节在布基纳法索进行了一项个体随机安慰剂对照试验。8 天至 59 个月大的儿童随机分为单次口服阿奇霉素（20mg/kg）或匹配安慰剂。在基线和治疗后 14 天，我们为所有儿童进行了快速诊断检测 (RDT) 以检测恶性疟原虫，并测量了所有儿童的鼓膜温度。在第 14 天就诊时记录了 caregiver报告的不良事件和就诊情况。
我们招募了 449 名儿童，其中 221 名随机分配至阿奇霉素组，228 名分配至安慰剂组。中位年龄为 32 个月，48%为女性。基线时共有 8%的儿童 RDT 检测疟原虫阳性，11%有发热（鼓膜温度≥37.5°C）。阿奇霉素组 14 天时 8%的儿童 RDT 检测疟原虫阳性，安慰剂组为 7%（P=0.65）。阿奇霉素组 15%的儿童发热≥37.5°C，安慰剂组为 21%（P=0.12）。与安慰剂组相比，阿奇霉素组儿童的看护者报告发热的不良事件发生率较低（OR 0.41，95%CI 0.18-0.96，P=0.04）。看护者报告的就诊情况很少见，两组之间无差异（P=0.32）。
我们没有发现单次口服阿奇霉素在高传播季节降低疟疾阳性率的证据。与安慰剂相比，接受阿奇霉素治疗的儿童中报告的发热较少，表明阿奇霉素可能对非疟疾感染有一定作用。
Clinicaltrials.gov NCT04315272，注册于 2020 年 3 月 19 日。
