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The Community Effectiveness of IPTi in Southern Tanzania

NCT ID: NCT00152204

Last Updated: 2008-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

13000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malaria, Falciparum Anemia

Keywords

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Use-Effectiveness Cost Effectiveness Patient Acceptance of Health Care Drug Resistance Delivery of Health Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Doses of IPTi with SP delivered alongside doses 2 \& 3 of DTP/HB vaccination and alongside measles vaccination

Group Type EXPERIMENTAL

Sulfadoxine-pyrimethamine used for IPTi

Intervention Type DRUG

Doses of IPTi with SP delivered alongside doses 2 \& 3 of DTP/HB vaccination and alongside measles vaccination

IPTi

Intervention Type DRUG

Doses of IPTi with SP delivered alongside doses 2 \& 3 of DTP/HB vaccination and alongside measles vaccination

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sulfadoxine-pyrimethamine used for IPTi

Doses of IPTi with SP delivered alongside doses 2 \& 3 of DTP/HB vaccination and alongside measles vaccination

Intervention Type DRUG

IPTi

Doses of IPTi with SP delivered alongside doses 2 \& 3 of DTP/HB vaccination and alongside measles vaccination

Intervention Type DRUG

Other Intervention Names

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Brand of SP used is Fanisdar SP brand being used is Fansidar

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ifakara Health Research and Development Centre

OTHER

Sponsor Role collaborator

Ministry of Health, Tanzania

OTHER_GOV

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role lead

Responsible Party

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London School of Hygiene & Tropical Medicine

Principal Investigators

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David M Schellenberg, MRCP PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene & Tropical Medicine, London, UK/Ifakara Health Research & Development Centre, Tanzania

Hassan Mshinda, PhD

Role: PRINCIPAL_INVESTIGATOR

Ifakara Health Research & Development Centre, Tanzania

Joanna RM Armstrong Schellenberg, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene & Tropical Medicine, London, UK/Ifakara Health Research & Development Centre, Tanzania

Pedro L Alonso, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic, Barcelona, Spain

Marcel Tanner, PhD

Role: PRINCIPAL_INVESTIGATOR

Swiss Tropical Institute, Basle, Switzerland

Locations

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Ifakara Health Research & Development Centre

Dar es Salaam, , Tanzania

Site Status

Countries

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Tanzania

References

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Shamba D, Schellenberg J, Hildon ZJ, Mashasi I, Penfold S, Tanner M, Marchant T, Hill Z. Thermal care for newborn babies in rural southern Tanzania: a mixed-method study of barriers, facilitators and potential for behaviour change. BMC Pregnancy Childbirth. 2014 Aug 11;14:267. doi: 10.1186/1471-2393-14-267.

Reference Type DERIVED
PMID: 25110173 (View on PubMed)

Maokola W, Chemba M, Hamisi Y, Mrisho M, Shirima K, Manzi F, Masanja M, Willey B, Alonso P, Mshinda H, Tanner M, Schellenberg JR, Schellenberg D. Safety of sulfadoxine/pyrimethamine for intermittent preventive treatment of malaria in infants: evidence from large-scale operational research in southern Tanzania. Int Health. 2011 Sep;3(3):154-9. doi: 10.1016/j.inhe.2011.03.009.

Reference Type DERIVED
PMID: 24038364 (View on PubMed)

Shamba DD, Schellenberg J, Penfold SC, Mashasi I, Mrisho M, Manzi F, Marchant T, Tanner M, Mshinda H, Schellenberg D, Hill Z. Clean home-delivery in rural Southern Tanzania: barriers, influencers, and facilitators. J Health Popul Nutr. 2013 Mar;31(1):110-7. doi: 10.3329/jhpn.v31i1.14755.

Reference Type DERIVED
PMID: 23617211 (View on PubMed)

Schellenberg JR, Maokola W, Shirima K, Manzi F, Mrisho M, Mushi A, Alonso P, Mshinda H, Tanner M, Schellenberg DM. Cluster-randomized study of intermittent preventive treatment for malaria in infants (IPTi) in southern Tanzania: evaluation of impact on survival. Malar J. 2011 Dec 30;10:387. doi: 10.1186/1475-2875-10-387.

Reference Type DERIVED
PMID: 22208409 (View on PubMed)

Penfold S, Hill Z, Mrisho M, Manzi F, Tanner M, Mshinda H, Schellenberg D, Armstrong Schellenberg JR. A large cross-sectional community-based study of newborn care practices in southern Tanzania. PLoS One. 2010 Dec 21;5(12):e15593. doi: 10.1371/journal.pone.0015593.

Reference Type DERIVED
PMID: 21203574 (View on PubMed)

Related Links

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http://www.ipti-malaria.org/

Intermittent Preventive Treatment in Infants (IPTi) Consortium

Other Identifiers

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BMGF28580

Identifier Type: -

Identifier Source: org_study_id