Malaria, FalciparumPhase 3NCT00152204
The Community Effectiveness of IPTi in Southern Tanzania
A Phase 3 study testing Sulfadoxine-pyrimethamine used for IPTi and IPTi in people with Malaria, Falciparum and Anemia, run by Swiss Tropical & Public Health Institute at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malaria, Falciparum, Anemia
- What is being tested?
- Sulfadoxine-pyrimethamine used for IPTi and IPTi
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,000 participants
- Where
- 1 siteTanzania
- Study dates
- Mar 2005to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- sensitivity to sulfadoxine-pyrimethamine or other sulfur-containing drugs
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Ifakara Health Research & Development Centre
Dar es Salaam, SLP 78373
About this study
Official title: Community Effectiveness of Intermittent Preventive Treatment Delivered Through the Expanded Programme of Immunisation for Malaria and Anaemia Control in Tanzanian Infants
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.
Read the 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.
- Conditions
- Malaria, Falciparum, Anemia
- Being tested
- Sulfadoxine-pyrimethamine used for IPTi, IPTi
- Keywords
- Use-Effectiveness, Cost Effectiveness, Patient Acceptance of Health Care, Drug Resistance, Delivery of Health Care
- Medical subject headings
- Malaria, Falciparum, Anemia, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxine-pyrimethamine used for IPTiDrug
Also called Brand of SP used is Fanisdar
Doses of IPTi with SP delivered alongside doses 2 \& 3 of DTP/HB vaccination and alongside measles vaccination
IPTiDrug
Also called SP brand being used is Fansidar
Doses of IPTi with SP delivered alongside doses 2 \& 3 of DTP/HB vaccination and alongside measles vaccination
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Doses of IPTi with SP delivered alongside doses 2 \& 3 of DTP/HB vaccination and alongside measles vaccination Receives: Drug: Sulfadoxine-pyrimethamine used for IPTi; Drug: IPTi |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate in children aged 2-11 months (estimated by birth history questioning)
Measured: Up to 12 months of age
Incidence of severe adverse drug reactions following IPTi (as detected by spontaneous, passive reporting system)
Measured: All age groups, particular attention in under 2 year olds
Secondary outcomes (3)
Prevalence of P falciparum parasitemia in children aged 2-11 months.
Measured: First year of life
Prevalence of anaemia (Hb<11 g/dL) in children aged 2-11 months.
Measured: First year of life
Period prevalence of fever without cough or diarrhoea (in preceding 2 weeks) in children aged 2-11 months.
Measured: First year of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionDec 2007
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Malaria, FalciparumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ifakara Health Research and Development Centre, Ministry of Health, Tanzania, Hospital Clinic of Barcelona, London School of Hygiene and Tropical Medicine
- Investigators
- David M Schellenberg, MRCP PhD, Principal investigator, London School of Hygiene & Tropical Medicine, London, UK/Ifakara Health Research & Development Centre, TanzaniaHassan Mshinda, PhD, Principal investigator, Ifakara Health Research & Development Centre, TanzaniaJoanna RM Armstrong Schellenberg, PhD, Principal investigator, London School of Hygiene & Tropical Medicine, London, UK/Ifakara Health Research & Development Centre, TanzaniaPedro L Alonso, MD PhD, Principal investigator, Hospital Clinic, Barcelona, SpainMarcel Tanner, PhD, Principal investigator, Swiss Tropical Institute, Basle, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152204
- Sponsor's protocol ID
- BMGF28580
- Status last verified
- May 2008
- First submitted
- 7 Sep 2005
- Last updated
- 22 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25110173Maokola 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.
PubMed 24038364Shamba 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.
PubMed 23617211Schellenberg 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.
PubMed 22208409Penfold 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.
PubMed 21203574
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Effectiveness of Intermittent Preventive Treatment Delivered Through the Expanded Programme of Immunisation for Malaria and Anaemia Control in Tanzanian Infants
- ClinicalTrials.gov ID
- NCT00152204
- Acronym / sponsor ID
- BMGF28580
- Conditions
- Malaria, Falciparum, Anemia
- Keywords
- Use-Effectiveness, Cost Effectiveness, Patient Acceptance of Health Care, Drug Resistance, Delivery of Health Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13,000 participants (estimated)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Ifakara Health Research and Development Centre, Ministry of Health, Tanzania, Hospital Clinic of Barcelona, London School of Hygiene and Tropical Medicine
- Study start
- Mar 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (estimated)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Sulfadoxine-pyrimethamine used for IPTi, Drug: IPTiDoses of IPTi with SP delivered alongside doses 2 \& 3 of DTP/HB vaccination and alongside measles vaccination |
| 2 | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- sensitivity to sulfadoxine-pyrimethamine or other sulfur-containing drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfadoxine-pyrimethamine used for IPTiAlso: Brand of SP used is FanisdarDoses of IPTi with SP delivered alongside doses 2 \& 3 of DTP/HB vaccination and alongside measles vaccination | Drug | 1 |
| IPTiAlso: SP brand being used is FansidarDoses of IPTi with SP delivered alongside doses 2 \& 3 of DTP/HB vaccination and alongside measles vaccination | Drug | 1 |
Primary outcome
Mortality rate in children aged 2-11 months (estimated by birth history questioning)
Time frame: Up to 12 months of age
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
3 secondary outcomes
Prevalence of P falciparum parasitemia in children aged 2-11 months.
Time frame: First year of life
Prevalence of anaemia (Hb<11 g/dL) in children aged 2-11 months.
Time frame: First year of life
Period prevalence of fever without cough or diarrhoea (in preceding 2 weeks) in children aged 2-11 months.
Time frame: First year of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
- Derived from this study: PubMed 25110173Shamba 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.
- Derived from this study: PubMed 24038364Maokola 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.
- Derived from this study: PubMed 23617211Shamba 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.
- Derived from this study: PubMed 22208409Schellenberg 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.
- Derived from this study: PubMed 21203574Penfold 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.
- Intermittent Preventive Treatment in Infants (IPTi) ConsortiumLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sulfadoxine-pyrimethamine used for IPTi and IPTi in people with Malaria, Falciparum and Anemia, run by Swiss Tropical & Public Health Institute at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate in children aged 2-11 months (estimated by birth history questioning) (time frame: Up to 12 months of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00152204, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2008.