The Community Effectiveness of IPTi in Southern Tanzania

May 21, 2008 updated by: Swiss Tropical & Public Health Institute

Community Effectiveness of Intermittent Preventive Treatment Delivered Through the Expanded Programme of Immunisation for Malaria and Anaemia Control in Tanzanian Infants

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A controlled trial of intermittent preventive malaria treatment in infants (IPTi) in southern Tanzania showed that treatment doses of antimalarial given to children at the time of routine vaccinations in the first year of life reduced the incidence of clinical malaria by 59% and halved the amount of severe anaemia. There were also useful reductions in presentations to hospital with fever (13%) and admission to hospital (30%). IPTi was safe, did not interfere with the serological response to EPI vaccines, cost approximately US$ 0.23 per child and the drug used (sulphadoxine-pyrimethamine) is readily available in Tanzania. Hence it is possible to reduce the rate of clinical malaria and severe anaemia by delivering an available and affordable drug through the existing EPI system in southern Tanzania.

Under the umbrella of the IPTi Consortium, a number of similar studies are now planned or underway to assess the safety and efficacy of IPTi in different settings and to confirm the non-interaction between various antimalarials used for IPTi and EPI vaccines. The aim is to generate robust information to inform a policy recommendation on the use of IPTi. The challenge will be to transform a positive policy recommendation into public health action in a short timeframe. Southern Tanzania is now in the unique position of being able to address the issues surrounding the development and implementation of IPTi as part of a district-based strategy to control malaria.

This project will develop, implement and evaluate a strategy for the delivery of IPTi to communities in five rural districts in southern Tanzania. IPTi will be delivered by routine health services in half of the facilities in the project area. Comparison of process and outcome indicators in areas with and without the IPTi strategy will provide an opportunity to consolidate the safety profile of IPTi and to evaluate its impact on (i) the rate of development of antimalarial drug resistance, (ii) perceptions and compliance with the EPI programme and (iii) infant health and survival patterns. The effectiveness evaluation will be linked to costing data to produce realistic estimates of cost effectiveness of the IPTi strategy.

Study Type

Interventional

Enrollment (Anticipated)

13000

Phase

  • Phase 3

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

  • Tanzania
      • Dar es Salaam, Tanzania, SLP 78373
        • Ifakara Health Research & Development Centre

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • child attending routine vaccination services for second or third dose of diptheria/pertussis/tetanus vaccinations (aged approximately two and three months, respectively) or for measles vaccination (aged approximately 9 months)

Exclusion Criteria:

  • sensitivity to sulfadoxine-pyrimethamine or other sulfur-containing drugs

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Experimental: 1
Doses of IPTi with SP delivered alongside doses 2 & 3 of DTP/HB vaccination and alongside measles vaccination
Drug: Sulfadoxine-pyrimethamine used for IPTi
Doses of IPTi with SP delivered alongside doses 2 & 3 of DTP/HB vaccination and alongside measles vaccination
Other Names:
  • Brand of SP used is Fanisdar
Drug: IPTi
Doses of IPTi with SP delivered alongside doses 2 & 3 of DTP/HB vaccination and alongside measles vaccination
Other Names:
  • SP brand being used is Fansidar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality rate in children aged 2-11 months (estimated by birth history questioning)
Time Frame: Up to 12 months of age
Up to 12 months of age
Incidence of severe adverse drug reactions following IPTi (as detected by spontaneous, passive reporting system)
Time Frame: All age groups, particular attention in under 2 year olds
All age groups, particular attention in under 2 year olds

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of P falciparum parasitemia in children aged 2-11 months.
Time Frame: First year of life
First year of life
Prevalence of anaemia (Hb<11 g/dL) in children aged 2-11 months.
Time Frame: First year of life
First year of life
Period prevalence of fever without cough or diarrhoea (in preceding 2 weeks) in children aged 2-11 months.
Time Frame: First year of life
First year of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Tropical & Public Health Institute

Collaborators

London School of Hygiene and Tropical Medicine
Hospital Clinic of Barcelona
Ifakara Health Research and Development Centre
Ministry of Health, Tanzania

Investigators

  • Principal Investigator: David M Schellenberg, MRCP PhD, London School of Hygiene & Tropical Medicine, London, UK/Ifakara Health Research & Development Centre, Tanzania
  • Principal Investigator: Hassan Mshinda, PhD, Ifakara Health Research & Development Centre, Tanzania
  • Principal Investigator: Joanna RM Armstrong Schellenberg, PhD, London School of Hygiene & Tropical Medicine, London, UK/Ifakara Health Research & Development Centre, Tanzania
  • Principal Investigator: Pedro L Alonso, MD PhD, Hospital Clinic, Barcelona, Spain
  • Principal Investigator: Marcel Tanner, PhD, Swiss Tropical Institute, Basle, Switzerland

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

Helpful Links

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, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 9, 2005

Study Record Updates

Last Update Posted (Estimate)

May 22, 2008

Last Update Submitted That Met QC Criteria

May 21, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMGF28580

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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