- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00111163
Intermittent Preventive Treatment With Antimalarials in Kenyan Infants
September 26, 2012 updated by: Centers for Disease Control and Prevention
Efficacy and Safety of Pediatric Immunization-linked Preventive Intermittent Treatment With Antimalarials in Decreasing Anemia and Malaria Morbidity in Rural Western Kenya
The purpose of the study is to see whether antimalarial drugs administered at the time of routine infant vaccinations prevents malaria and anemia in the first year of life.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Approximately three quarters of preschool children in eastern Africa suffer from anemia, defined as a hemoglobin (Hb) concentration below 11 g/dL.
For children < 5 years of age, the overall incidence of severe malarial anemia (Hb < 5 g/dl) is estimated at 15-60 cases per 1,000 children per year.
Other studies have confirmed that the burden of malaria-related anemia falls primarily on infants and young children.
In 2000, Schellenberg and colleagues, working in an area of Tanzania with a low to moderate level of Plasmodium falciparum transmission and a low level of sulfadoxine-pyrimethamine (SP) resistance, demonstrated that by linking intermittent prophylaxis to routine immunization visits through the national Expanded Program on Immunization (EPI), SP could be administered to children at 2,3, and 9 months of age, resulting in a 59% reduction in rates of clinical malaria and a 50% reduction in the rate of severe anemia (Hb<8 g/dl) compared to those receiving placebo.
This randomized, double blind, placebo-controlled trial is being conducted to estimate the efficacy of Intermittent Preventive Treatment for Infants (IPTi) with SP + three doses of artesunate (AS) (SP/AS3) given in combination with iron supplementation from 2-6 months of age at routine EPI visits on the prevention of clinical malaria, moderate anemia, and severe anemia in the first 18 months of life in an area with intense malaria transmission and near universal ownership of insecticide treated nets (ITNs).
The primary objective is to compare the efficacy of iron supplementation and IPTi with one of 3 antimalarial regimens (SP/AS3, chlorproguanil-dapsone (Lapdap), or AQ/AS3) given at routine EPI visits with iron supplementation alone (+ placebo) on the prevention of clinical malaria in the first year of life.
Specific secondary objectives are: 1) Compare the efficacy of iron supplementation plus IPTi with one of 3 antimalarial regimens (SP/AS3, Lapdap [chlorproguanil-dapsone], or AQ/AS3) given at routine EPI visits with iron supplementation alone (+ placebo) on the prevention of moderate and severe anemia in the first year of life; 2) Assess the impact of IPTi with the aforementioned regimens on serologic responses to EPI vaccines (Polio, Diphtheria, Tetanus, Pertussis, Hepatitis B, Hemophilus Influenzae type B, and Measles; 3) Assess the impact of IPTi with the aforementioned regimens (particularly SP/AS3) on the nasal carriage rates of Haemophilus influenza type b; and 4) Compare the efficacy of iron supplementation and IPTi with one of 3 antimalarial regimens (SP/AS3, Lapdap [chlorproguanil-dapsone], or AQ/AS3) given at routine EPI visits with iron supplementation alone (+ placebo) on the prevention of all-cause hospitalization in the first year of life.
This trial will generate important public health information on the efficacy of IPTi in preventing anemia and clinical malaria among infants in an area with intense malaria transmission and ongoing prevention efforts through the use of insecticide treated nets.
This trial will contribute towards understanding IPTi's mechanism of action (i.e. through intermittent clearance of parasites vs. a chemoprophylactic effect afforded through the use of an antimalarial with a long half-life).
The information gained will be useful to determine the safety of IPTi, and to decide what sort of antimalarials are appropriate for IPTi, and ultimately will help to direct child survival and malaria control policy in African countries.
If alternative drug regimes to SP prove effective, that information will be valuable to policymakers as levels of P. falciparum resistance to SP rise with increased usage in east Africa.
Study Type
Interventional
Enrollment
1516
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nyanza Province
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Asembo (Rarieda Division), Nyanza Province, Kenya
- Lwak, Abidha, Ongielo and Saradidi clinics
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 3 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Presenting for Pentavalent 1 immunization
- Age 5 weeks to 16 weeks
- Parent or guardian currently resident in study catchment area
- Parent or guardian has given permission for their child to participate
Exclusion Criteria:
- Known allergy to any of the study drugs
- Current Cotrimoxazole prophylaxis
- Concomitant disease requiring hospitalization or transfusion
- Plans to be away from the study area for more than 6 months during the next year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Clinical malaria in the first year of life
|
Secondary Outcome Measures
Outcome Measure |
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Moderate and severe anemia in the first year of life
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Serologic responses to Expanded Program on Immunization (EPI) vaccines (Polio, Diphtheria, Tetanus, Pertussis, Hepatitis B, Hemophilus Influenzae type B, and Measles)
|
Nasal carriage rates of Haemophilus influenza type b
|
All cause hospitalization in the first year of life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert D Newman, MD, MPH, U.S. Centers for Disease Control and Prevention
- Principal Investigator: Laurence Slutsker, MD, MPH, U.S. Centers for Disease Control and Prevention
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1016/S0140-6736(00)04643-2.
- 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.
- Odhiambo FO, Hamel MJ, Williamson J, Lindblade K, ter Kuile FO, Peterson E, Otieno P, Kariuki S, Vulule J, Slutsker L, Newman RD. Intermittent preventive treatment in infants for the prevention of malaria in rural Western kenya: a randomized, double-blind placebo-controlled trial. PLoS One. 2010 Apr 2;5(4):e10016. doi: 10.1371/journal.pone.0010016.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
May 17, 2005
First Submitted That Met QC Criteria
May 17, 2005
First Posted (Estimate)
May 18, 2005
Study Record Updates
Last Update Posted (Estimate)
September 27, 2012
Last Update Submitted That Met QC Criteria
September 26, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Hematologic Diseases
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Anemia
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Anti-Bacterial Agents
- Leprostatic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Anthelmintics
- Folic Acid Antagonists
- Schistosomicides
- Antiplatyhelmintic Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Pyrimethamine
- Dapsone
- Artesunate
- Chlorproguanil
- Sulfadoxine
- Fanasil, pyrimethamine drug combination
- Amodiaquine
Other Study ID Numbers
- CDC-NCID-3606
- SSC 701
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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