The Community Effectiveness of IPTi in Southern Tanzania
Primary Purpose
Malaria, Falciparum, Anemia
Status
Unknown status
Phase
Phase 3
Locations
Tanzania
Study Type
Interventional
Intervention
Sulfadoxine-pyrimethamine used for IPTi
IPTi
Sponsored by
About this trial
This is an interventional prevention trial for Malaria, Falciparum focused on measuring Use-Effectiveness, Cost Effectiveness, Patient Acceptance of Health Care, Drug Resistance, Delivery of Health Care
Eligibility 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
Sites / Locations
- Ifakara Health Research & Development Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Doses of IPTi with SP delivered alongside doses 2 & 3 of DTP/HB vaccination and alongside measles vaccination
Outcomes
Primary Outcome Measures
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 Outcome Measures
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.
Full Information
NCT ID
NCT00152204
First Posted
September 7, 2005
Last Updated
May 21, 2008
Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Ifakara Health Research and Development Centre, Ministry of Health, Tanzania, Hospital Clinic of Barcelona, London School of Hygiene and Tropical Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00152204
Brief Title
The Community Effectiveness of IPTi in Southern Tanzania
Official Title
Community Effectiveness of Intermittent Preventive Treatment Delivered Through the Expanded Programme of Immunisation for Malaria and Anaemia Control in Tanzanian Infants
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Ifakara Health Research and Development Centre, Ministry of Health, Tanzania, Hospital Clinic of Barcelona, London School of Hygiene and Tropical Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Falciparum, Anemia
Keywords
Use-Effectiveness, Cost Effectiveness, Patient Acceptance of Health Care, Drug Resistance, Delivery of Health Care
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Doses of IPTi with SP delivered alongside doses 2 & 3 of DTP/HB vaccination and alongside measles vaccination
Arm Title
2
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Sulfadoxine-pyrimethamine used for IPTi
Other Intervention Name(s)
Brand of SP used is Fanisdar
Intervention Description
Doses of IPTi with SP delivered alongside doses 2 & 3 of DTP/HB vaccination and alongside measles vaccination
Intervention Type
Drug
Intervention Name(s)
IPTi
Other Intervention Name(s)
SP brand being used is Fansidar
Intervention Description
Doses of IPTi with SP delivered alongside doses 2 & 3 of DTP/HB vaccination and alongside measles vaccination
Primary Outcome Measure Information:
Title
Mortality rate in children aged 2-11 months (estimated by birth history questioning)
Time Frame
Up to 12 months of age
Title
Incidence of severe adverse drug reactions following IPTi (as detected by spontaneous, passive reporting system)
Time Frame
All age groups, particular attention in under 2 year olds
Secondary Outcome Measure Information:
Title
Prevalence of P falciparum parasitemia in children aged 2-11 months.
Time Frame
First year of life
Title
Prevalence of anaemia (Hb<11 g/dL) in children aged 2-11 months.
Time Frame
First year of life
Title
Period prevalence of fever without cough or diarrhoea (in preceding 2 weeks) in children aged 2-11 months.
Time Frame
First year of life
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Schellenberg, MRCP PhD
Organizational Affiliation
London School of Hygiene & Tropical Medicine, London, UK/Ifakara Health Research & Development Centre, Tanzania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hassan Mshinda, PhD
Organizational Affiliation
Ifakara Health Research & Development Centre, Tanzania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanna RM Armstrong Schellenberg, PhD
Organizational Affiliation
London School of Hygiene & Tropical Medicine, London, UK/Ifakara Health Research & Development Centre, Tanzania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pedro L Alonso, MD PhD
Organizational Affiliation
Hospital Clinic, Barcelona, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcel Tanner, PhD
Organizational Affiliation
Swiss Tropical Institute, Basle, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ifakara Health Research & Development Centre
City
Dar es Salaam
ZIP/Postal Code
SLP 78373
Country
Tanzania
12. IPD Sharing Statement
Citations:
PubMed Identifier
25110173
Citation
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.
Results Reference
derived
PubMed Identifier
23617211
Citation
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.
Results Reference
derived
PubMed Identifier
22208409
Citation
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.
Results Reference
derived
PubMed Identifier
24038364
Citation
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.
Results Reference
derived
PubMed Identifier
21203574
Citation
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.
Results Reference
derived
Links:
URL
http://www.ipti-malaria.org/
Description
Intermittent Preventive Treatment in Infants (IPTi) Consortium
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The Community Effectiveness of IPTi in Southern Tanzania
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