Assessing the Safety and Efficacy of a Combination Therapy for STH in PSAC in Bangladesh

Children will receive the medication after being randomly assigned to either treatment arm. Albendazole will be administered as a syrup and ivermectin tablets as powdered tablets because ivermectin suspension is not available in Bangladesh. The commercially available 6 mg unscored Ivermectin tablets will be crushed, the tablet fragments ground into a powder, and stored in an airtight plastic container in a dry, cool environment after all aseptic procedures. According to the weight of the children, the investigators will provide the needed amount (weighted by microgram scale) of the drug mixed with 5 ml of water. The study field staff will help the parents to give the medicine to the child by the direct observation therapy (DOT) method. The parents will be advised to bring the children on an empty stomach in the morning. Ivermectin will be given first, and a light snack will be provided 30 minutes after taking ivermectin. Then albendazole will be given to the children.

Albendazole will be given in syrup form. The study field staff will help the parents to give the medicine to the child by the direct observation therapy (DOT) method. The parents will be advised to bring the children on an empty stomach in the morning. Ivermectin will be given first, and a light snack will be provided 30 minutes after taking ivermectin. Then albendazole will be given to the children. Both drugs will be given using direct observation at the field clinic. Parents will be advised to report any adverse effects, including vomiting, after taking the medication. If vomiting occurs within one hour of medication, a redosing will be provided.