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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 Negl Trop Dis] 2019 Apr 10; Vol. 13 (4), pp. e0007238. Date of Electronic Publication: 2019 Apr 10 (Print Publication: 2019). - Publication Year :
- 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.<br />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.<br />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.<br />Conclusion: The efficacy of China-made praziquantel does not differ significantly from praziquantel made by Merck KGaA in Germany.<br />Trial Registration: ClinicalTrials.gov, NCT03133832.<br />Competing Interests: The authors have declared that no competing interests exist.
- Subjects :
- Adolescent
Adult
Aged
Animals
Chemoprevention
Child
Child, Preschool
China
Female
Humans
Male
Middle Aged
Parasite Egg Count
Schistosomiasis haematobia urine
Tanzania
Treatment Outcome
Young Adult
Anthelmintics standards
Anthelmintics therapeutic use
Praziquantel standards
Praziquantel therapeutic use
Schistosoma haematobium drug effects
Schistosomiasis haematobia drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1935-2735
- Volume :
- 13
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- PLoS neglected tropical diseases
- Publication Type :
- Academic Journal
- Accession number :
- 30969960
- Full Text :
- https://doi.org/10.1371/journal.pntd.0007238