We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Community Effectiveness of IPTi in Southern Tanzania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00152204
Recruitment Status : Unknown
Verified May 2008 by Swiss Tropical & Public Health Institute.
Recruitment status was:  Active, not recruiting
First Posted : September 9, 2005
Last Update Posted : May 22, 2008
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

Brief 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.

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

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  (Clinical Trial)
Estimated Enrollment : 13000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2005
Primary Completion Date : December 2007
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Malaria
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Mortality rate in children aged 2-11 months (estimated by birth history questioning) [ Time Frame: Up to 12 months of age ]
  2. 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 ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: May 22, 2008
Last Verified: May 2008

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
Fanasil, pyrimethamine drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents