Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia

Condition(s) targeted: Sickle Cell Anemia; Malaria

Intervention: sulfadoxine pyrimethamine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Makerere University

Official(s) and/or principal investigator(s):
Victoria Nakibuuka, MBChB, Principal Investigator, Affiliation: Department of Paediatrics and Child Health , Makerere University
Grace Ndeezi, M.Med, Principal Investigator, Affiliation: Department of Paediatrics and Child Health, Makerere University
Deborah Nakiboneka, M.Med, Principal Investigator, Affiliation: Department of Paediatrics and Child Health, Makerere University
Christopher Ndugwa, PhD, Principal Investigator, Affiliation: Department of paediatrics and Child Health, Makerere University
James Tumwine, PhD, Principal Investigator, Affiliation: Department of Paediatrics and Child Health, Makerere University

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.

Official title: Presumptive Treatment With Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prophylaxis in Children With Sickle Cell Anemia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Malaria episodes

Secondary outcome:

Malaria related admissions

Adverse drug effects

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 )

Minimum age: 6 Months. Maximum age: 12 Years. Gender(s): Both.

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

Mulago Hospital, Kampala, Central 256, Uganda

Related publications:

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.

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.

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.

Starting date: October 2006
Last updated: July 1, 2009