Safety Surveillance of Mass Praziquantel and Albendazole Co-Administration in School Children from Southern Ethiopia: An Active Cohort Event Monitoring

Abstract

Preventive chemotherapy (PC) with praziquantel and albendazole co-administration to all at-risk populations is the global intervention strategy to eliminate schistosomiasis and soil-transmitted helminth (STH) from being public health problems. Due to weak pharmacovigilance systems, safety monitoring during a mass drug administration (MDA) is lacking, especially in sub-Saharan Africa. We conducted large-scale active safety surveillance to identify the incidence, types, severity, and associated risk factors of adverse events (AEs) following praziquantel and albendazole MDA in 5848 school children (5–15 years old). Before MDA, 1484 (25.4%) children were prescreened for S. mansoni and STH infections, of whom 71.8% were infected with at least one parasite; 34.5% (512/1484) had S. mansoni and 853 (57.5%) had an STH infection. After collecting the baseline socio-demographic, clinical, and medical data, including any pre-existing clinical symptoms, participants received single dose praziquantel and albendazole MDA. Treatment-associated AEs were actively monitored on days 1 and 7 of the MDA. The events reported before and after the MDA were cross-checked and verified to identify MDA-associated AEs. The cumulative incidence of experiencing at least one type of MDA-associated AE was 13.3% (95% CI = 12.5–14.2%); 85.5%, 12.4%, and 1.8% of reported AEs were mild, moderate, and severe, respectively. The proportion of experiencing one, two, or ≥ three types of AEs was 57.7%, 34.1%, and 8.2%, respectively. The cumulative incidence of AEs in S. mansoni- and (17.0%) and STH (14.1%)-infected children was significantly higher (p < 0.001, χ2 = 15.0) than in non-infected children (8.4%). Headache, abdominal pain, vomiting, dizziness, and nausea were the most common AEs. Being female, older age, having S. mansoni or STH infection were significant predictors of MDA-associated AEs. In summary, praziquantel and albendazole co-administration is generally safe and tolerable. MDA-associated AEs are mostly mild-to-moderately severe and transient. The finding of few severe AEs and significantly high rates of AEs in helminth-infected children underscores the need to integrate pharmacovigilance in MDA programs, especially in high schistosomiasis and STH endemic areas.

Efficacy and safety of praziquantel treatment against Schistosoma mansoni infection among pre-school age children in southern Ethiopia

“…Pre-SAC with heavy baseline infection intensity had a 6.5 times increased risk of experiencing an AE, and those with moderate infection intensity experienced a 3.2 times increased risk compared to those with light infection intensity. A similar finding was reported by a study conducted in the same area among SAC [ 45 ]. Thus, safety monitoring of PZQ administration to pre-SAC living in hyper-endemic villages and high pre-treatment infection intensity remains crucial.…”

Endemic status of urogenital schistosomiasis and the efficacy of a single-dose praziquantel treatment in unmapped rural farming communities in Oyo East Local Government Area, Oyo State, Nigeria

“…The significant egg reduction among heavily infected individuals, in this study, would impact positively on the severe morbidity and disease transmission in the Ajagba community. Generally, in sub-Saharan Africa, praziquantel treatment has drastically reduced morbidity and transmission of schistosomiasis [17,[47][48][49]. The singledose of praziquantel at 40 mg/kg body weight, in this study, appeared to be more effective against heavy infections than the light infections.…”

Comparative Safety Surveillance of Triple (IDA) Versus Dual Therapy (DA) in Mass Drug Administration for Elimination of Lymphatic Filariasis in Kenya: A Cohort Event Monitoring Study

“…This is also consistent with results from other studies [ 14 , 36 ]. Higher rates of MDA-associated AEs in female individuals than in male individuals who received IDA for LF in Tanzania [ 29 ], or praziquantel and albendazole in Ethiopia and Rwanda have been reported recently [ 30 , 37 ]. Significant variation in the rate of treatment-related AEs between male and female individuals could be due to sex-dependent biological and physiological differences influencing drug metabolism and disposition [ 38 , 39 ].…”