The Community Effectiveness of IPTi in Southern Tanzania

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Swiss Tropical & Public Health Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Ifakara Health Research and Development Centre
Ministry of Health, Tanzania
Hospital Clinic of Barcelona
London School of Hygiene and Tropical Medicine
Information provided by:
Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier:
NCT00152204
First received: September 7, 2005
Last updated: May 21, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Malaria, Falciparum
Anemia
Drug: Sulfadoxine-pyrimethamine used for IPTi
Drug: IPTi
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Community Effectiveness of Intermittent Preventive Treatment Delivered Through the Expanded Programme of Immunisation for Malaria and Anaemia Control in Tanzanian Infants

Resource links provided by NLM:


Further study details as provided by Swiss Tropical & Public Health Institute:

Primary Outcome Measures:
  • Mortality rate in children aged 2-11 months (estimated by birth history questioning) [ Time Frame: Up to 12 months of age ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Prevalence of P falciparum parasitemia in children aged 2-11 months. [ Time Frame: First year of life ] [ Designated as safety issue: No ]
  • Prevalence of anaemia (Hb<11 g/dL) in children aged 2-11 months. [ Time Frame: First year of life ] [ Designated as safety issue: No ]
  • Period prevalence of fever without cough or diarrhoea (in preceding 2 weeks) in children aged 2-11 months. [ Time Frame: First year of life ] [ Designated as safety issue: No ]

Estimated Enrollment: 13000
Study Start Date: March 2005
Estimated Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: SP brand being used is Fansidar
No Intervention: 2

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152204

Locations
Tanzania
Ifakara Health Research & Development Centre
Dar es Salaam, Tanzania, SLP 78373
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Ifakara Health Research and Development Centre
Ministry of Health, Tanzania
Hospital Clinic of Barcelona
London School of Hygiene and Tropical Medicine
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
  More Information

Additional Information:
No publications provided by Swiss Tropical & Public Health Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Schellenberg, London School of Hygiene & Tropical Medicine
ClinicalTrials.gov Identifier: NCT00152204     History of Changes
Other Study ID Numbers: BMGF28580
Study First Received: September 7, 2005
Last Updated: May 21, 2008
Health Authority: Tanzania: National Institute for Medical Research

Keywords provided by Swiss Tropical & Public Health Institute:
Use-Effectiveness
Cost Effectiveness
Patient Acceptance of Health Care
Drug Resistance
Delivery of Health Care

Additional relevant MeSH terms:
Anemia
Malaria
Malaria, Falciparum
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Sulfadoxine-pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on April 17, 2014