MalariaNCT00766662
Intermittent Preventive Treatment in Infant in Mali
A study testing Sulfadoxine pyrimethamine in people with Malaria, run by University of Bamako at 1 site in Mali.
Trial summary
Studies have shown that Intermittent preventive treatment in infants (IPTi) with Sulfadoxine-pyrimethamine (SP)reduced the incidence of clinical malaria and anemia without modifying infants' serological response to EPI vaccines. Read more about this study
- Who is it for?
- Ages Up to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Sulfadoxine pyrimethamine
- How many people
- Not given
- Where
- 1 siteMali
- Study dates
- Oct 2006to Dec 2007
- Phase
- Interventional
- 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 Up to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Resident of Kolokani, Mali
- Age less than 24 months
Who cannot join
- Not Resident of Kolokani
- Age of 24 months or above
Trial locations and contacts
1 site in 1 country.
Mali1 site
Malaria Research & Training Center; Faculty of Medicine, Pharmacy and Dentistry, University of Bamako
Bamako, 0000
About this study
Studies have shown that Intermittent preventive treatment in infants (IPTi) with Sulfadoxine-pyrimethamine (SP)reduced the incidence of clinical malaria and anemia without modifying infants' serological response to EPI vaccines. Thus IPTi was seen as a potential public health tool of great benefit to the children of Africa and a logical addition to the Immunization Plus package. The objectives of this operational researcher were
- to develop an implementation model for IPTi in the health care system in Mali
- to assess its impact on the EPI vaccines and other health interventions coverage
- and on molecular makers of resistance to SP
Read the detailed description
The study was implemented in districts of the region of Koulikoro; the district of Koulikoro and the district of Kolokani. The whole district of Koulikoro was covered by the intervention while in Kolokani, the 22 health areas (sub districts) were randomized in 1:1 ratio with the intervention in 11 health areas and the other 11 serving as control for the assessment of the impact of IPTi implementation on EPI vaccines and other health interventions coverage as well as its impact on the resistance to SP. The implementation consisted of administration of ½ tablet of Sulfadoxine -Pyrimethamine with EPI vaccines (DTP2, DTP3 and Measles vaccine) from December 2006 to December 2007.
- Conditions
- Malaria
- Being tested
- Sulfadoxine pyrimethamine
- Keywords
- Malaria, Intermittent Preventive Treatment, EPI vaccine coverage, Resistance of P. falciparum to Sulfadoxine- Pyrimethamine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxine pyrimethamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
EPI vaccines and other health interventions coverage
Measured: 1 year
Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startOct 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Bamako
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF
- Investigators
- Alassane Dicko, MD, Principal investigator, Faculty of Medicine, Pharmacy and Dentistry; University of BamakoOgobara K Doumbo, MD, Study director, Faculty of Medicine, Pharmacy and Dentistry; University of Bamako
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766662
- Sponsor's protocol ID
- 06-55
- Status last verified
- Sep 2008
- First submitted
- 3 Oct 2008
- Last updated
- 6 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Dicko A, Konare M, Traore D, Testa J, Salamon R, Doumbo O, Rogier C. The implementation of malaria intermittent preventive trialtreatment with sulphadoxine-pyrimethamine in infants reduced all-cause mortality in the district of Kolokani, Mali: results from a cluster randomized control. Malar J. 2012 Mar 16;11:73. doi: 10.1186/1475-2875-11-73.
PubMed 22423611Dicko A, Toure SO, Traore M, Sagara I, Toure OB, Sissoko MS, Diallo AT, Rogier C, Salomon R, de Sousa A, Doumbo OK. Increase in EPI vaccines coverage after implementation of intermittent preventive treatment of malaria in infant with Sulfadoxine -pyrimethamine in the district of Kolokani, Mali: results from a cluster randomized control trial. BMC Public Health. 2011 Jul 18;11:573. doi: 10.1186/1471-2458-11-573.
PubMed 21767403
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Preventive Treatment in Infant in Mali
- ClinicalTrials.gov ID
- NCT00766662
- Acronym / sponsor ID
- 06-55
- Conditions
- Malaria
- Keywords
- Malaria, Intermittent Preventive Treatment, EPI vaccine coverage, Resistance of P. falciparum to Sulfadoxine- Pyrimethamine
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of BamakoUniversity, hospital or other
- Collaborators
- UNICEF
- Study start
- Oct 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Oct 2008 (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.
Studies have shown that Intermittent preventive treatment in infants (IPTi) with Sulfadoxine-pyrimethamine (SP)reduced the incidence of clinical malaria and anemia without modifying infants' serological response to EPI vaccines. Thus IPTi was seen as a potential public health tool of great benefit to the children of Africa and a logical addition to the Immunization Plus package. The objectives of this operational researcher were
- to develop an implementation model for IPTi in the health care system in Mali
- to assess its impact on the EPI vaccines and other health interventions coverage
- and on molecular makers of resistance to SP
Detailed description
The study was implemented in districts of the region of Koulikoro; the district of Koulikoro and the district of Kolokani. The whole district of Koulikoro was covered by the intervention while in Kolokani, the 22 health areas (sub districts) were randomized in 1:1 ratio with the intervention in 11 health areas and the other 11 serving as control for the assessment of the impact of IPTi implementation on EPI vaccines and other health interventions coverage as well as its impact on the resistance to SP. The implementation consisted of administration of ½ tablet of Sulfadoxine -Pyrimethamine with EPI vaccines (DTP2, DTP3 and Measles vaccine) from December 2006 to December 2007.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Resident of Kolokani, Mali
- Age less than 24 months
Key exclusion criteria (2 listed)
- Not Resident of Kolokani
- Age of 24 months or above
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 | Drug | – |
Primary outcome
EPI vaccines and other health interventions coverage
Time frame: 1 year
Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2008.
- Derived from this study: PubMed 22423611Dicko A, Konare M, Traore D, Testa J, Salamon R, Doumbo O, Rogier C. The implementation of malaria intermittent preventive trialtreatment with sulphadoxine-pyrimethamine in infants reduced all-cause mortality in the district of Kolokani, Mali: results from a cluster randomized control. Malar J. 2012 Mar 16;11:73. doi: 10.1186/1475-2875-11-73.
- Derived from this study: PubMed 21767403Dicko A, Toure SO, Traore M, Sagara I, Toure OB, Sissoko MS, Diallo AT, Rogier C, Salomon R, de Sousa A, Doumbo OK. Increase in EPI vaccines coverage after implementation of intermittent preventive treatment of malaria in infant with Sulfadoxine -pyrimethamine in the district of Kolokani, Mali: results from a cluster randomized control trial. BMC Public Health. 2011 Jul 18;11:573. doi: 10.1186/1471-2458-11-573.
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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.
Alassane Dicko, MD principal investigator
Faculty of Medicine, Pharmacy and Dentistry; University of Bamako
Ogobara K Doumbo, MD study director
Faculty of Medicine, Pharmacy and Dentistry; University of Bamako
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulfadoxine pyrimethamine in people with Malaria, run by University of Bamako at 1 site in Mali.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 6 Oct 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 Mali. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
EPI vaccines and other health interventions coverage (time frame: 1 year). 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 NCT00766662, which also lists 2 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 6 Oct 2008.