Evaluation of Effectiveness of ALBENDAZOLIVERMECTIN Coformulation vs ALBENDAZOLE for Treatment of Intestinal Worms (ALIVE)
Helminthes; Infestation, Intestinal
About this trial
This is an interventional treatment trial for Helminthes; Infestation, Intestinal focused on measuring soil-transmitted helminths, pediatric, adult, albendazole, ivermectin, coformulation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 followup, as per investigator's criteria.
- Known hypersensitivity to any components of either of the study treatment.
- Positive pregnancy urine test, pregnant or first week postpartum.
Sites / Locations
- Bahir Dar University, Colleges of Medicine and Health Sciences (BDU-CMHS)
- Kenya Medical Research Institute (KEMRI)
- Centro de Investigação em Saúde da Manhiça (CISM)
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Albendazole
FDCx1. Albendazole and Ivermectin Fixed Dose Coformulation
FDCx3. Albendazole and Ivermectin Fixed Dose Coformulation 3 days
Albendazole 400 mg single dose
Single dose of a tablet of FDC 400mg18mg or 400mg9mg. (i) For participants <45 kg of body weight at baseline: FDC of 400mg ALB 9mg IVM. (ii) For participants ≥45 kg of body weight at baseline: FDC of 400mg ALB18mg IVM
Daily dose of a tablet of FDC 400mg18mg or 400mg 9mg for 3 days. (i)For participants <45 kg of body weight at baseline: FDC of 400mg ALB9mg IVM. (ii) For participants ≥45 kg of body weight at baseline: FDC of 400mg ALB 18mg IVM.