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	Phase III

Further Study Details: 

Primary Outcomes: Mortality rate in children aged 2-11 months (estimated by birth history questioning); Incidence of severe adverse drug reactions following IPTi (as detected by spontaneous, passive reporting system)
Secondary Outcomes: Prevalence of P falciparum parasitemia in children aged 2-11 months.; Prevalence of anaemia (Hb<11 g/dL) in children aged 2-11 months.; Period prevalence of fever without cough or diarrhoea (in preceding 2 weeks) in children aged 2-11 months.
Expected Total Enrollment:  13000

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.

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00152204

David M Schellenberg, MRCP PhD      + 255 748 633 273    DMSchellenberg@AOL.COM

Tanzania
      Ifakara Health Research & Development Centre, Dar es Salaam,  SLP 78373,  Tanzania; Recruiting

Study chairs or principal investigators

David M Schellenberg, MRCP PhD,  Principal Investigator,  London School of Hygiene & Tropical Medicine, London, UK/Ifakara Health Research & Development Centre, Tanzania   
Hassan Mshinda, PhD,  Principal Investigator,  Ifakara Health Research & Development Centre, Tanzania   
Joanna RM Armstrong Schellenberg, PhD,  Principal Investigator,  London School of Hygiene & Tropical Medicine, London, UK/Ifakara Health Research & Development Centre, Tanzania   
Pedro L Alonso, MD PhD,  Principal Investigator,  Hospital Clinic, Barcelona, Spain   
Marcel Tanner, PhD,  Principal Investigator,  Swiss Tropical Institute, Basle, Switzerland   

Study ID Numbers:  BMGF28580
Last Updated:  September 8, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00152204
Health Authority: Tanzania: National Institute for Medical Research
ClinicalTrials.gov processed this record on 2005-09-13