Malaria Clinical Trial
Official title:
Presumptive Treatment With Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prophylaxis in Children With Sickle Cell Anemia
Verified date | July 2009 |
Source | Makerere University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Uganda: National Council for Science and Technology |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 220 |
Est. completion date | February 2007 |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 12 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Uganda | Mulago Hospital | Kampala | Central |
Lead Sponsor | Collaborator |
---|---|
Makerere University |
Uganda,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Malaria episodes | 4 weeks | No | |
Secondary | Malaria related admissions | 1 month | No | |
Secondary | Adverse drug effects | 4 weeks | Yes |
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