The Community Effectiveness of IPTi in Southern Tanzania

NCT00152204 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13000

Last updated 2008-05-22

No results posted yet for this study

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

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00152204 on ClinicalTrials.gov