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

NCT00152204 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Swiss Tropical & Public Health Institute
Phase	Phase 3
Status	UNKNOWN
Enrolment	13000
Start date	2005-03
Completion	2008-12

Conditions

• Malaria, Falciparum
• Anemia

Interventions

• Sulfadoxine-pyrimethamine used for IPTi
• IPTi

Primary outcomes

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

Countries

Tanzania