Anemia Clinical Trial
Official title:
Community Effectiveness of Intermittent Preventive Treatment Delivered Through the Expanded Programme of Immunisation for Malaria and Anaemia Control in Tanzanian Infants
Verified date | May 2008 |
Source | Swiss Tropical & Public Health Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Unknown status |
Enrollment | 13000 |
Est. completion date | December 2008 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Tanzania | Ifakara Health Research & Development Centre | Dar es Salaam |
Lead Sponsor | Collaborator |
---|---|
Swiss Tropical & Public Health Institute | Hospital Clinic of Barcelona, Ifakara Health Research and Development Centre, London School of Hygiene and Tropical Medicine, Ministry of Health, Tanzania |
Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality rate in children aged 2-11 months (estimated by birth history questioning) | Up to 12 months of age | ||
Primary | 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 | ||
Secondary | Prevalence of P falciparum parasitemia in children aged 2-11 months. | First year of life | ||
Secondary | Prevalence of anaemia (Hb<11 g/dL) in children aged 2-11 months. | First year of life | ||
Secondary | Period prevalence of fever without cough or diarrhoea (in preceding 2 weeks) in children aged 2-11 months. | First year of life |
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