PMID- 38124206 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231223 IS - 1348-8945 (Print) IS - 1349-4147 (Electronic) IS - 1348-8945 (Linking) VI - 51 IP - 1 DP - 2023 Dec 20 TI - Efficacy and safety of praziquantel treatment against Schistosoma mansoni infection among pre-school age children in southern Ethiopia. PG - 72 LID - 10.1186/s41182-023-00562-4 [doi] LID - 72 AB - BACKGROUND: Preventive chemotherapy with a single dose of praziquantel given to an all-at-risk population through mass drug administration is the cornerstone intervention to control and eliminate schistosomiasis as a public health problem. This intervention mainly targets school age children, and pre-school age children (pre-SAC) are excluded from receiving preventive chemotherapy, partly due to scarcity of data on praziquantel treatment outcomes. METHODS: We conducted active efficacy and safety surveillance of praziquantel treatment among 240 Schistosoma mansoni-infected pre-SAC who received a single dose of praziquantel (40 mg/kg) in southern Ethiopia. The study outcomes were egg reduction rates (ERR) and cure rates (CRs) four weeks after treatment using the Kato-Katz technique and treatment-associated adverse events (AEs) that occurred within 8 days post-treatment. RESULTS: The overall ERR was 93.3% (WHO reference threshold >/= 90%), while the CR was 85.2% (95% CI = 80.0-89.5%). Baseline S. mansoni infection intensity was significantly associated with CRs, 100% among light infected than moderate (83.4%) or heavy (29.4%) infected children. An increase of 100 in baseline S. mansoni egg count per gram of stool resulted in a 26% (95% CI: 17%, 34%) reduction in the odds of cure. The incidence of experiencing at least one type of AE was 23.1% (95% CI: 18.0%, 29.0%). Stomachache, diarrhea, and nausea were the most common AEs. AEs were mild-to-moderate grade and transient. Pre-treatment moderate (ARR = 3.2, 95% CI: 1.69, 6.14) or heavy infection intensity (ARR = 6.5, 95% CI: 3.62, 11.52) was a significant predictor of AEs (p < 0.001). Sex, age, or soil-transmitted helminth coinfections were not significant predictors of CR or AEs. CONCLUSIONS: Single-dose praziquantel is tolerable and effective against S. mansoni infection among pre-SAC, and associated AEs are mostly mild-to-moderate and transient. However, the reduced CR in heavily infected and AEs in one-fourth of S. mansoni-infected pre-SAC underscores the need for safety and efficacy monitoring, especially in moderate-to-high infection settings. Integrating pre-SACs in the national deworming programs is recommended to accelerate the elimination of schistosomiasis as a public health problem. CI - (c) 2023. The Author(s). FAU - Tadele, Tafese AU - Tadele T AD - School of Public Health, College of Medicine and Health Sciences, Hawassa University, P.O. Box 1560, Hawassa, Ethiopia. FAU - Astatkie, Ayalew AU - Astatkie A AD - School of Public Health, College of Medicine and Health Sciences, Hawassa University, P.O. Box 1560, Hawassa, Ethiopia. FAU - Tadesse, Birkneh Tilahun AU - Tadesse BT AD - Department of Pediatrics, College of Medicine and Health Sciences, Hawassa University, P.O. Box 1560, Hawassa, Ethiopia. FAU - Makonnen, Eyasu AU - Makonnen E AD - Center for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University, P.O. Box 9086, Addis Ababa, Ethiopia. AD - Department of Pharmacology and Clinical Pharmacy, College of Health Sciences, Addis Ababa University, P.O. Box 9086, Addis Ababa, Ethiopia. FAU - Aklillu, Eleni AU - Aklillu E AUID- ORCID: 0000-0002-9788-0790 AD - Department of Global Public Health, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden. eleni.aklillu@ki.se. FAU - Abay, Solomon Mequanente AU - Abay SM AD - Department of Pharmacology and Clinical Pharmacy, College of Health Sciences, Addis Ababa University, P.O. Box 9086, Addis Ababa, Ethiopia. LA - eng GR - CSA2016S-1618/European and Developing Countries Clinical Trials Partnership/ GR - TMA2018CDF-2345/European and Developing Countries Clinical Trials Partnership/ GR - CSA2016S-1618/Styrelsen for Internationellt Utvecklingssamarbete/ PT - Journal Article DEP - 20231220 PL - Japan TA - Trop Med Health JT - Tropical medicine and health JID - 101215093 PMC - PMC10731898 OTO - NOTNLM OT - Cure rate OT - Efficacy OT - Egg reduction rate OT - Ethiopia OT - Pharmacovigilance OT - Praziquantel OT - Pre-school age children OT - Safety OT - Schistosomiasis, Schistosoma mansoni COIS- The authors declare no conflict of interest. EDAT- 2023/12/21 06:43 MHDA- 2023/12/21 06:44 PMCR- 2023/12/20 CRDT- 2023/12/21 00:12 PHST- 2023/09/24 00:00 [received] PHST- 2023/12/09 00:00 [accepted] PHST- 2023/12/21 06:44 [medline] PHST- 2023/12/21 06:43 [pubmed] PHST- 2023/12/21 00:12 [entrez] PHST- 2023/12/20 00:00 [pmc-release] AID - 10.1186/s41182-023-00562-4 [pii] AID - 562 [pii] AID - 10.1186/s41182-023-00562-4 [doi] PST - epublish SO - Trop Med Health. 2023 Dec 20;51(1):72. doi: 10.1186/s41182-023-00562-4.