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

NCT00399074 | Completed Phase 3

• 1 other identifier: 2004/HD11/1353U
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Anemia; Malaria

Keywords

Sickle Cell anemia; Malaria; Presumptive treatment; Sulfadoxine- pyrimethamine; Children; Uganda

Outcome Measures

Primary Outcomes (1)

• Malaria episodes

  4 weeks

Secondary Outcomes (2)

• Malaria related admissions

  1 month

• Adverse drug effects

  4 weeks

Study Arms (2)

chloroquine

NO INTERVENTION

Weekly CQ

Sulfadoxine-pyrimethamine

NO INTERVENTION

Monthly SP

Drug: sulfadoxine pyrimethamine

Interventions

sulfadoxine pyrimethamine DRUG

Monthly SP

Also known as: SP

Sulfadoxine-pyrimethamine

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Mulago Hospital

Kampala, Central Region, 256, Uganda

Location

Related Publications (3)

• 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.

  PMID: 11377597 BACKGROUND

• 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.

  PMID: 12788572 BACKGROUND

• 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.

  PMID: 16503464 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Malaria

Interventions

fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 13, 2006
• First Posted: November 14, 2006
• Study Start: October 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: July 2, 2009

Record last verified: 2009-07

Locations

UG (1)