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

This study has been completed.
Sponsor:
Information provided by:
Makerere University
ClinicalTrials.gov Identifier:
NCT00399074
First received: November 13, 2006
Last updated: July 1, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Sickle Cell Anemia
Malaria
Drug: sulfadoxine pyrimethamine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Presumptive Treatment With Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prophylaxis in Children With Sickle Cell Anemia

Resource links provided by NLM:


Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Malaria episodes [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Malaria related admissions [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Adverse drug effects [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 220
Study Start Date: October 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: chloroquine
Weekly CQ
No Intervention: Sulfadoxine-pyrimethamine
Monthly SP
Drug: sulfadoxine pyrimethamine
Monthly SP
Other Name: SP

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 )

  Eligibility

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399074

Locations
Uganda
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
  More Information

Publications:
Responsible Party: James K Tumwine, Department of Paediatrics and Child Health Makerere University
ClinicalTrials.gov Identifier: NCT00399074     History of Changes
Other Study ID Numbers: 2004/HD11/1353U
Study First Received: November 13, 2006
Last Updated: July 1, 2009
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Makerere University:
Sickle Cell anemia
Malaria
Presumptive treatment
Sulfadoxine- pyrimethamine
Children
Uganda

Additional relevant MeSH terms:
Anemia
Malaria
Anemia, Sickle Cell
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Chloroquine
Chloroquine diphosphate
Sulfadoxine
Pyrimethamine
Fanasil, pyrimethamine drug combination
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on September 18, 2014