Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT00550160
Eligibility Criteria:
Inclusion Criteria:
* A child in the study cohort will be eligible to receive a course of IPTc (active or placebo) if the child has NO fever (a temperature of 37•5o C or above) or history of fever in the last 24 hours. However, fever is only a temporary exclusion criterion. If a child has fever when he/she is due for an IPTc course, treatment will be given for the fever and the IPTc course given one month after the fever has subsided. This interval between treatment of fever episodes and administration of an IPTc course is proposed in order to minimise the risk of overdosing since the same drug is used for both HMM and IPTc.
Exclusion Criteria:
* A child in the study cohort will not be eligible to receive a course of IPTc if:
* The child has a clinical condition that may be classified as severe according to IMCI guidelines.
* The child is known to suffer from chronic disease(s) e.g. sickle cell disease that might adversely affect the interpretation of study results.
* The mother/caregiver withdraws consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
59 Months
Study:
NCT00550160
Study Brief:
Protocol Section:
NCT00550160