Presumptive Treatment With Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prophylaxis in Children With Sickle Cell Anemia
Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia
Sponsors
Source
Makerere University
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 )
Overall Status
Completed
Start Date
2006-10-01
Completion Date
2007-02-01
Primary Completion Date
2007-02-01
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Malaria episodes |
4 weeks |
Secondary Outcome
Measure |
Time Frame |
|
Malaria related admissions |
1 month |
|
Adverse drug effects |
4 weeks |
Enrollment
220
Conditions
Intervention
Intervention Type
Drug
Intervention Name
Description
Monthly SP
Arm Group Label
Sulfadoxine-pyrimethamine
Other Name
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
Gender
All
Minimum Age
6 Months
Maximum Age
12 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Victoria Nakibuuka, MBChB |
Principal Investigator |
Department of Paediatrics and Child Health , Makerere University |
|
Grace Ndeezi, M.Med |
Principal Investigator |
Department of Paediatrics and Child Health, Makerere University |
|
Deborah Nakiboneka, M.Med |
Principal Investigator |
Department of Paediatrics and Child Health, Makerere University |
|
Christopher Ndugwa, PhD |
Principal Investigator |
Department of paediatrics and Child Health, Makerere University |
|
James Tumwine, PhD |
Principal Investigator |
Department of Paediatrics and Child Health, Makerere University |
Location
Facility |
|
Mulago Hospital Kampala Central 256 Uganda |
Location Countries
Country
Uganda
Verification Date
2009-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Name Title
James K Tumwine
Organization
Department of Paediatrics and Child Health Makerere University
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Chloroquine
Chloroquine diphosphate
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
Arm Group
Arm Group Label
chloroquine
Arm Group Type
No Intervention
Description
Weekly CQ
Arm Group Label
Sulfadoxine-pyrimethamine
Arm Group Type
No Intervention
Description
Monthly SP
Firstreceived Results Date
N/A
Reference
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.
PMID
11377597
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.
PMID
12788572
Citation
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.
PMID
16503464
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
November 13, 2006
Study First Submitted Qc
November 13, 2006
Study First Posted
November 14, 2006
Last Update Submitted
July 1, 2009
Last Update Submitted Qc
July 1, 2009
Last Update Posted
July 2, 2009
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.