MalariaNCT00623155
Seasonal Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine in Children in Mali
A study testing Seasonal IPT in children - Sulfadoxine-pyrimethamine in people with Malaria, run by University of Bamako at 1 site in Mali.
Trial summary
Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being… Read more about this study
- Who is it for?
- Ages 6 months to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Seasonal IPT in children - Sulfadoxine-pyrimethamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteMali
- Study dates
- Jul 2002to Jan 2004
- 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 6 months to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6 months to 10 years
- Agree to seek initial medical care for all medical illness in the study clinic during the study period
- Written informed consent by a parent or legal garden,
- No plan to travel for a long time during the study period.
Who cannot join
- History of allergy to sulfa drugs or Sulfadoxine-pyrimethamine
- Chronic illness or symptomatic malaria at the time of enrollment
Trial locations and contacts
1 site in 1 country.
Mali1 site
Malaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry, University of Bamako
Bamako
About this study
Official title: Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management
Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.
- Conditions
- Malaria
- Being tested
- Seasonal IPT in children - Sulfadoxine-pyrimethamine
- Keywords
- malaria, intermittent preventive treatment, season, children
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seasonal IPT in children - Sulfadoxine-pyrimethamineDrug
Subjecs randomized to receive two intermittent preventive treatments with standard recommended treatment doses of Sulfadoxine-pyrimethamine at 8 weeks interval during the peak malaria transmission season.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Control group |
| 2 | Experimental | Test group Receives: Drug: Seasonal IPT in children - Sulfadoxine-pyrimethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence rate of clinical malaria
in vivo adequate clinical and parasitological response of P. falciparum to SP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startJul 2002
- Primary completionJul 2003
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bamako
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Investigators
- Ogobara Doumbo, MD, Study director, University of BamakoAlassane Dicko, MD, Principal investigator, University of Bamako
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623155
- Sponsor's protocol ID
- A10828
- Status last verified
- Sep 2002
- First submitted
- 14 Feb 2008
- Last updated
- 25 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Dicko A, Sagara I, Sissoko MS, Guindo O, Diallo AI, Kone M, Toure OB, Sacko M, Doumbo OK. Impact of intermittent preventive treatment with sulphadoxine-pyrimethamine targeting the transmission season on the incidence of clinical malaria in children in Mali. Malar J. 2008 Jul 8;7:123. doi: 10.1186/1475-2875-7-123.
PubMed 18611271
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management
- ClinicalTrials.gov ID
- NCT00623155
- Acronym / sponsor ID
- A10828
- Conditions
- Malaria
- Keywords
- malaria, intermittent preventive treatment, season, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- University of BamakoUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- Jul 2002
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 25 Feb 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.
Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Control group |
| 2 | Experimental | Drug: Seasonal IPT in children - Sulfadoxine-pyrimethamineTest group |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 6 months to 10 years
- Agree to seek initial medical care for all medical illness in the study clinic during the study period
- Written informed consent by a parent or legal garden,
- No plan to travel for a long time during the study period.
Key exclusion criteria (2 listed)
- History of allergy to sulfa drugs or Sulfadoxine-pyrimethamine
- Chronic illness or symptomatic malaria at the time of enrollment
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 |
|---|---|---|
| Seasonal IPT in children - Sulfadoxine-pyrimethamineSubjecs randomized to receive two intermittent preventive treatments with standard recommended treatment doses of Sulfadoxine-pyrimethamine at 8 weeks interval during the peak malaria transmission season. | Drug | 2 |
Primary outcome
incidence rate of clinical malaria
in vivo adequate clinical and parasitological response of P. falciparum to SP
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 25 Feb 2008.
- Derived from this study: PubMed 18611271Dicko A, Sagara I, Sissoko MS, Guindo O, Diallo AI, Kone M, Toure OB, Sacko M, Doumbo OK. Impact of intermittent preventive treatment with sulphadoxine-pyrimethamine targeting the transmission season on the incidence of clinical malaria in children in Mali. Malar J. 2008 Jul 8;7:123. doi: 10.1186/1475-2875-7-123.
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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.
Ogobara Doumbo, MD study director
University of Bamako
Alassane Dicko, MD principal investigator
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 Seasonal IPT in children - 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 4 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 25 Feb 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?
incidence rate of clinical malaria. 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 NCT00623155, which also lists 1 linked publication.
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 25 Feb 2008.