The Community Effectiveness of IPTi in Southern Tanzania
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
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| Tanzania | |
| Ifakara Health Research & Development Centre | |
| Dar es Salaam, Tanzania, SLP 78373 | |
| 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 May 19, 2013