Evaluating the effectiveness and cost-effectiveness of integrating mass drug administration for helminth control with seasonal malaria chemoprevention in Ghanaian childre
- Conditions
- MalariaNeglected Tropical Diseases - Soil Transmitted Helminths and schistosomiasis
- Registration Number
- PACTR202312489417172
- Lead Sponsor
- ondon School of Hygiene Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 1200
• Male and female children aged 1-14 years;
• Provision of written informed consent by the parent/caregiver and a positive assent by children aged = 7 years (in line with legal regulations in Ghana);
• Willingness to provide finger prick blood samples, urine, and stool samples;
• Residence in the study area for at least the past six months and willingness to be available in the study area for follow-up about 6 months after enrolment.
•Acutely ill child at the time of the drug administration;
•A child whose parents/care-givers decline to provide consent;
•A known HIV-positive child receiving co-trimoxazole prophylaxis;
•A child who has received a dose of either Sulphadoxine-pyrimethamine (SP), amodiaquine (AQ), albendazole (ALB) or praziquantel (PZQ) during the previous six months;
•A child with a known allergy to any of SP, AQ, ALB, or PZQ
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Haemoglobin (Hb) concentration, measured by HemoCue®,
- Secondary Outcome Measures
Name Time Method • Incidence of clinical malaria, defined as fever of >37.5oC or a history of fever in the preceding 48 hours, and a positive malaria blood film with a parasite density of >0 per µl, detected by passive case detection during the surveillance period.<br>• Change in prevalence of anaemia on the day of inclusion, at subsequent findings and post-intervention at the end of malaria transmission season; anaemia will be defined as Hb less than 11 g/dl.<br>• The incidence of solicited adverse events and adverse drug reactions assessed to be related to the study medications during a period of six consecutive days after administration of study drugs. <br>• Prevalence and density of P.falciparum infection; prevalence and density of helminth infection; and prevalence and density of malaria-helminth co-infection<br>