The Community Effectiveness of IPTi in Southern Tanzania
NCT00152204 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13000
Last updated 2008-05-22
Summary
The safety and efficacy of Intermittent Preventive Treatment for malaria and anaemia control in Infants (IPTi) have already been documented in Southern Tanzania, affording an opportunity to gain operational experience in developing a strategy for the longer-term implementation of IPTi. Working in conjunction with national and district-based health authorities, a strategy will be developed to make IPTi available through routine health services and an effectiveness evaluation conducted. This will be based on the comparison of process and outcome indicators in areas with and without IPTi. Information on safety will be consolidated and the effect of IPTi on the rate of development of drug resistance explored. The acceptability and costs of implementing IPTi will be monitored and combined with assessments of effectiveness (in terms of morbidity and mortality) to assess the cost-effectiveness of IPTi.
Conditions
- Malaria, Falciparum
- Anemia
Interventions
- DRUG
-
Sulfadoxine-pyrimethamine used for IPTi
Doses of IPTi with SP delivered alongside doses 2 \& 3 of DTP/HB vaccination and alongside measles vaccination
- DRUG
-
IPTi
Doses of IPTi with SP delivered alongside doses 2 \& 3 of DTP/HB vaccination and alongside measles vaccination
Sponsors & Collaborators
-
Ifakara Health Research and Development Centre
collaborator OTHER -
Ministry of Health, Tanzania
collaborator OTHER_GOV -
Hospital Clinic of Barcelona
collaborator OTHER -
London School of Hygiene and Tropical Medicine
collaborator OTHER -
Swiss Tropical & Public Health Institute
lead OTHER
Principal Investigators
-
David M Schellenberg, MRCP PhD · London School of Hygiene & Tropical Medicine, London, UK/Ifakara Health Research & Development Centre, Tanzania
-
Hassan Mshinda, PhD · Ifakara Health Research & Development Centre, Tanzania
-
Joanna RM Armstrong Schellenberg, PhD · London School of Hygiene & Tropical Medicine, London, UK/Ifakara Health Research & Development Centre, Tanzania
-
Pedro L Alonso, MD PhD · Hospital Clinic, Barcelona, Spain
-
Marcel Tanner, PhD · Swiss Tropical Institute, Basle, Switzerland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2005-03-31
- Primary Completion
- 2007-12-31
- Completion
- 2008-12-31
Countries
- Tanzania
Study Locations
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