Lao Tropical and Public Health Institute (Lao TPHI)
Vientiane, Laos
NCT Number: NCT07262814
This study aims to assess the efficacy, safety and acceptability of ascending doses of arpraziquantel in children infected with Opisthorchis viverrini. The primary objective is to determine the dose-response relationship in terms of cure rate. This study will involve children aged 6-7 years, since O. viverrini infections often occur in pre-school and school-aged children, and this group is largely left untreated in current public health programs.
Trial opening soon.
Get Notified6 year–7 year
All sexes
Interventional
Phase 2
Vientiane, Laos
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tablets (dispersible) containing 150 mg arpraziquantel
Time frame: 21-28 days after treatment
CRs will be calculated as the percentage of O. viverrini egg-positive participants at baseline who become egg-negative after treatment.
Time frame: 21-28 days after treatment
Eggs per gram of stool (EPG) will be assessed by calculating the mean egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of 24. Geometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs.
Time frame: 3 hours, 24 hours, 21-28 days and 42 days after treatment
Participants will be monitored at the site for 3 hours following treatment for any acute adverse events (AEs). Participants will be interviewed 3 hours and 24 hours after treatment, as well as 21-28 days and 42 days after treatment administration about the occurrence of AEs. AEs will be evaluated descriptively as the difference of proportion reported AEs before and after treatment.
Contact information is provided by the study sponsor or research team.
Jennifer Keiser
Other
Efficacy, Safety and Acceptability of Ascending Doses of Arpraziquantel for Opisthorchis Viverrini Infections in Children Aged 6-7 Years: A Single-blind Randomized Dose-ranging Trial
Acronym: ADORA-VI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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