Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia
Study Details
Study Description
Brief Summary
Malaria is fatal and increases the risk of death among children with sickle cell anemia. Chemoprophylaxis significantly improves quality of life in these children. In Uganda Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due to high levels of resistance throughout the country. Intermittent presumptive treatment with sulfadoxine - Pyrimethamine a new approach to malaria prevention, has shown great potential in reducing incidence of malaria and anaemia among high risk groups such as pregnant women and infants. However no studies have been done in Uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces the incidence of malaria in children with sickle cell anaemia.
Hypothesis : Presumptive treatment with sulfadoxine- Pyrimethamine is better than weekly chloroquine in reducing incidence of malaria in children with sickle cell anaemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Malaria is fatal and increases the risk of death among children with sickle cell anemia. Chemoprophylaxis significantly improves quality of life in these children. In Uganda Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due to high levels of resistance throughout the country. Intermittent presumptive treatment with sulfadoxine - pyrimethamine a new approach to malaria prevention, has shown great potential in reducing incidence of malaria and anemia among high risk groups such as pregnant women and infants. However no studies have been done in Uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces incidence of malaria among high risk group such as children with sickle cell anaemia.
We calculated a sample size of 110 patients in each group for a power of 95% assuming that the incidence of malaria in children receiving weekly chloroquine will be 0.36 and those receiving presumptive treatment with sulfadoxine - pyrimethamine the incidence would be 0.16 according to (schellenberg et al )
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: chloroquine Weekly CQ |
|
| No Intervention: Sulfadoxine-pyrimethamine Monthly SP |
Drug: sulfadoxine pyrimethamine
Monthly SP
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Malaria episodes [4 weeks]
Secondary Outcome Measures
- Malaria related admissions [1 month]
- Adverse drug effects [4 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Children aged 6 months to 12 years attending sickle cell clinic in Mulago Hospital during the study period with a negative peripheral smear for parasites, adherence to appointment visits, consent by care takers to participate in the study.
Exclusion Criteria:
- Patients with known allergy to sulfonamides, Patients with severe illnesses requiring urgent admission, Patients with documented treatment for malaria in the past one month with Sulfadoxine- Pyrimethamine. Patients on cotrimoxazole prophylaxis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mulago Hospital | Kampala | Central | Uganda | 256 |
Sponsors and Collaborators
- Makerere University
Investigators
- Principal Investigator: Victoria Nakibuuka, MBChB, Department of Paediatrics and Child Health , Makerere University
- Principal Investigator: Grace Ndeezi, M.Med, Department of Paediatrics and Child Health, Makerere University
- Principal Investigator: Deborah Nakiboneka, M.Med, Department of Paediatrics and Child Health, Makerere University
- Principal Investigator: Christopher Ndugwa, PhD, Department of paediatrics and Child Health, Makerere University
- Principal Investigator: James Tumwine, PhD, Department of Paediatrics and Child Health, Makerere University
Study Documents (Full-Text)
None provided.More Information
Publications
- Cissé B, Sokhna C, Boulanger D, Milet J, Bâ el H, Richardson K, Hallett R, Sutherland C, Simondon K, Simondon F, Alexander N, Gaye O, Targett G, Lines J, Greenwood B, Trape JF. Seasonal intermittent preventive treatment with artesunate and sulfadoxine-pyrimethamine for prevention of malaria in Senegalese children: a randomised, placebo-controlled, double-blind trial. Lancet. 2006 Feb 25;367(9511):659-67.
- Massaga JJ, Kitua AY, Lemnge MM, Akida JA, Malle LN, Rønn AM, Theander TG, Bygbjerg IC. Effect of intermittent treatment with amodiaquine on anaemia and malarial fevers in infants in Tanzania: a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1853-60.
- Schellenberg D, Menendez C, Kahigwa E, Aponte J, Vidal J, Tanner M, Mshinda H, Alonso P. Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial. Lancet. 2001 May 12;357(9267):1471-7.
- 2004/HD11/1353U