Efficacy of China-made praziquantel for treatment of Schistosomiasis haematobium in Africa: A randomized controlled trial

Background: In the roadmap on the neglected tropical diseases (NTD) the World Health Organization (WHO) aims at attaining at least 75% coverage of preventive chemotherapy in pre-school and school-age children by 2020. A randomized controlled trial was used to compare the effectiveness of praziquantel in treating Schistosoma haematobium in Africa using two different sources for the drug, Merck Limited Partnership (KgaA), Germany and Nanjing Pharmaceutical Factory (NPF), China. Methods: More than 6,000 participants testing positive for S. haematobium infection were enrolled from three villages (shehias) situated in the northern, middle and southern part of Pemba Island, Zanzibar. Applying criteria of inclusion and exclusion, resulted in a study population of 152 people (84 males, 68 females). A randomized controlled trial was conducted assigning participants to either praziquantel from NPF or Merck KGaA. After one month, the cure rate of S. haematobium and adverse events were compared to evaluate effectiveness. The ratio of male to female, the ratio of light/high infection intensity, and the average value of age were calculated between the two drug manufacturers. Chi-squared test and T-test were used for consistency analysis. Results: Out of the total of 73 cases receiving praziquantel from NPF, the cure rate achieved was 97.3% (73/75), while the 74 cases receiving the drug from Merck KgaA reached a similar cure rate (96.1% or 74/77). There was no significant difference between the two outcomes (χ2 = 0.003, P = 0.956). Among the 75 patients treat, only one (a 16-years old female student), who had received the drug made in China had slight adverse reactions manifested as dizziness, headache and abdominal pain. Conclusion: The efficacy of China-made praziquantel does not differ significantly from praziquantel made by Merck KGaA in Germany. Trial registration: ClinicalTrials.gov, NCT03133832 Author summary: Schistosomiasis is a neglected tropical disease (NTD) with praziquantel the only effective drug available. It is estimated that about 800 million people are currently at risk for this disease with more than 200 million people infected. A large drug donation partnership between Merck, Darmstadt, Germany and the World Health Organization supports widespread, successful preventive chemotherapy programs, but the donated drugs does not meet the entire need, particularly not in Africa. The primary aim of our study was to evaluate the efficacy of China-made praziquantel to explore whether the drug could complement preventive chemotherapy programs in Africa. A randomized controlled trial was conducted assigning participants to two groups, one receiving praziquantel from NPF, the other from Merck KGaA. After one month, the cure rate of S. haematobium and were compared to evaluate effectiveness and document potential adverse events. The outcome showed that the two sources of praziquantel that did not differ significantly from each other. China-made praziquantel can thus be trusted to complement the current use of the drug from Merck KGaA in Africa making it possible to enlarge drug provision programs.