NCT00152204

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 22, 2008

Status Verified

May 1, 2008

Enrollment Period

2.8 years

First QC Date

September 7, 2005

Last Update Submit

May 21, 2008

Conditions

Malaria, FalciparumAnemia

Keywords

Use-EffectivenessCost EffectivenessPatient Acceptance of Health CareDrug ResistanceDelivery of Health Care

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (3)

  • Prevalence of P falciparum parasitemia in children aged 2-11 months.

    First year of life

  • Prevalence of anaemia (Hb<11 g/dL) in children aged 2-11 months.

    First year of life

  • Period prevalence of fever without cough or diarrhoea (in preceding 2 weeks) in children aged 2-11 months.

    First year of life

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Sulfadoxine-pyrimethamine used for IPTiDrug: IPTi

2

NO INTERVENTION

Interventions

Sulfadoxine-pyrimethamine used for IPTiDRUG

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

Also known as: Brand of SP used is Fanisdar
1
IPTiDRUG

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

Also known as: SP brand being used is Fansidar
1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • sensitivity to sulfadoxine-pyrimethamine or other sulfur-containing drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ifakara Health Research & Development Centre

Dar es Salaam, SLP 78373, Tanzania

Location

Related Publications (5)

  • 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.

    PMID: 25110173DERIVED

  • 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.

    PMID: 24038364DERIVED

  • 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.

    PMID: 23617211DERIVED

  • 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.

    PMID: 22208409DERIVED

  • 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.

    PMID: 21203574DERIVED

Related Links

MeSH Terms

Conditions

Malaria, FalciparumAnemiaPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHematologic DiseasesHemic and Lymphatic DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 9, 2005

Study Start

March 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2008

Last Updated

May 22, 2008

Record last verified: 2008-05

Locations

TA(1)