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Efficacy of China-made praziquantel for treatment of Schistosomiasis haematobium in Africa: A randomized controlled trial
- Source :
- PLoS Neglected Tropical Diseases, PLoS Neglected Tropical Diseases, Vol 13, Iss 4, p e0007238 (2019)
- Publication Year :
- 2019
- Publisher :
- Public Library of Science (PLoS), 2019.
-
Abstract
- 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<br />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.
- Subjects :
- Male
0301 basic medicine
Tanzania
Praziquantel
law.invention
Schistosomiasis haematobia
0302 clinical medicine
Randomized controlled trial
law
Medicine
Child
Anthelmintics
Schistosoma haematobium
biology
lcsh:Public aspects of medicine
Middle Aged
Treatment Outcome
Infectious Diseases
Child, Preschool
Neglected tropical diseases
Population study
Female
Research Article
medicine.drug
Adult
China
medicine.medical_specialty
lcsh:Arctic medicine. Tropical medicine
Adolescent
lcsh:RC955-962
030231 tropical medicine
Chemoprevention
Young Adult
03 medical and health sciences
Pharmacotherapy
Internal medicine
parasitic diseases
Animals
Humans
Adverse effect
Parasite Egg Count
Aged
business.industry
Public Health, Environmental and Occupational Health
lcsh:RA1-1270
biology.organism_classification
Clinical trial
030104 developmental biology
business
Subjects
Details
- ISSN :
- 19352735
- Volume :
- 13
- Database :
- OpenAIRE
- Journal :
- PLOS Neglected Tropical Diseases
- Accession number :
- edsair.doi.dedup.....a102c2cf777d8db3a0b0af6dcce91e9e