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

NCT ID: NCT00399074

Last Updated: 2009-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-02-28

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.

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 )

Conditions

Sickle Cell Anemia; Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

chloroquine

Weekly CQ

Group Type: NO_INTERVENTION

No interventions assigned to this group

Sulfadoxine-pyrimethamine

Monthly SP

Group Type: NO_INTERVENTION

sulfadoxine pyrimethamine

Intervention Type: DRUG

Monthly SP

Interventions

sulfadoxine pyrimethamine

Monthly SP

Intervention Type: DRUG

Other Intervention Names

SP

Eligibility 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Makerere University

OTHER

Sponsor Role: lead

Responsible Party

Department of Paediatrics and Child Health Makerere University

Principal Investigators

Victoria Nakibuuka, MBChB

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatrics and Child Health , Makerere University

Grace Ndeezi, M.Med

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatrics and Child Health, Makerere University

Deborah Nakiboneka, M.Med

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatrics and Child Health, Makerere University

Christopher Ndugwa, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of paediatrics and Child Health, Makerere University

James Tumwine, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatrics and Child Health, Makerere University

Locations

Mulago Hospital

Kampala, Central Region, Uganda

Countries

Uganda

References

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. doi: 10.1016/S0140-6736(00)04643-2.

Reference Type: BACKGROUND

PMID: 11377597 (View on PubMed)

Massaga JJ, Kitua AY, Lemnge MM, Akida JA, Malle LN, Ronn 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. doi: 10.1016/s0140-6736(03)13504-0.

Reference Type: BACKGROUND

PMID: 12788572 (View on PubMed)

Cisse B, Sokhna C, Boulanger D, Milet J, Ba 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. doi: 10.1016/S0140-6736(06)68264-0.

Reference Type: BACKGROUND

PMID: 16503464 (View on PubMed)

Other Identifiers

2004/HD11/1353U

Identifier Type: -

Identifier Source: org_study_id