An Adaptive phase II/III Single-Blinded, Randomized, Multi-Centre, Parallel-Group, Active-Controlled, Superiority Study to Evaluate the Safety and Efficacy of a Single Day or 3-day Single Dose of an ALBENDAZOLE-IVERMECTIN Coformulation vs ALBENDAZOLE for the Treatment of Soil-Transmitted Helminth Infections (Trichuris trichiura, hookworm, Strongyloides stercoralis) in Paediatric and Young Adult Population.

Barcelona Institute for Global Health ISGlobal0 个研究点目标入组 1,223 人开始时间: 2020年10月15日最近更新: 2023年5月29日

研究概览

暂无简介。

•Positive infection test by microscopy for at least one of the following STH: T. trichiura, hookworms and/or larvae of S. stercoralis.
•Weight =15 Kg.
•Male or female, aged 5 to 18 years.
•Female participants who are =12 years old (or female post-menarche) must have a negative urine pregnancy test at screening or at the time of randomization.
•Ability to take oral medication and willingness to comply with all study procedures.
•Parental acceptance to participate in the study by obtaining a signed and dated informed consent form approved by the Regulatory authorities. In addition, verbal assent will be obtained from children aged 12–18 years.

•Intake of ALB, mebendazole and/or IVM, or any potentially interacting drug three months before screening.
•Residence outside the study area or planning to move away in the four weeks following recruitment.
•Epidemiological risk of infection by Loa loa.
•Serious medical illness, per investigator’s criteria.
•Any participant’s condition that would prevent the appropriate evaluation and follow-up, as per investigator’s criteria.
•Known hypersensitivity to any components of either of the study treatment.
•Positive pregnancy urine test, pregnant or first week post-partum.

发起方

Barcelona Institute for Global Health ISGlobal