MalariaPhase 1/2NCT00209794
IPTi in Mozambican Infants for Malaria Prevention
A Phase 1/2 study testing Sulfadoxine-Pyrimethamine (Fansidar) in people with Malaria, run by Hospital Clinic of Barcelona at 1 site in Mozambique.
Trial summary
To evaluate if intermittent preventive treatment in infants (IPTi) consisting of SP [Fansidar] given through the EPI scheme alongside routine immunisations at 3, 4 and 9 months of age reduces de incidence of clinical malaria up to 12 months of age Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Malaria
- What is being tested?
- Sulfadoxine-Pyrimethamine (Fansidar)
- How many people
- 1,498 participants
- Where
- 1 siteMozambique
- Study dates
- Sep 2002to Dec 2005
- Phase
- Phase 1/2
- 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 3 months
- All sexes
- Child
Who may be able to join
- Children from study area
- Signed informed consent
Who cannot join
- History of drug allergies
Trial locations and contacts
1 site in 1 country.
Mozambique1 site
Centro de Investigaçao em Saude da Manhiça
Manhiça, Maputo Province
About this study
Official title: The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children
To evaluate if intermittent preventive treatment in infants (IPTi) consisting of SP [Fansidar] given through the EPI scheme alongside routine immunisations at 3, 4 and 9 months of age reduces de incidence of clinical malaria up to 12 months of age
Read the detailed description
The study is a randomised, double blind, placebo-controlled trial of the antimalarial drug sulphadoxine-pyrimethamine administered intermittently at 3, 4 and 9 months of age through the EPI scheme at the time of routine immunisations.
Children will be randomized into placebo and SP treatment groups by block randomization, and it is expected a similar age distribution and a similar number of children in each group.
Doses of sulphadoxine (25 mg/kg)-pyrimethamine (1.25 mg/kg) (SP) or placebo will be given by a health assistant according to bodyweight (a quarter of a tablet for those <5kg, a half for those 5-10 kg, and a whole tablet for children >10 kg). The tablets will be crashed and diluted with water for their administration.
- Conditions
- Malaria
- Being tested
- Sulfadoxine-Pyrimethamine (Fansidar)
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxine-Pyrimethamine (Fansidar)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of first or only malaria episodes in each study cohort by 12 months of age.
Secondary outcomes (11)
Incidence of first or only malaria episodes by group up to 12 months of age as per protocol analysis.
Incidence of first or only malaria episodes by group up to 24 months of age.
Incidence of multiple malaria episodes up to 12 months of age.
Incidence of multiple malaria episodes up to 24 months of age.
Incidence of overall and severe anaemia up to 12 months of age.
Incidence of overall and severe anaemia up to 24 months of age.
Proportion of humoral and cellular immune responses against malaria at 12 months of age.
Total number of admissions and outpatient attendances up to 24 months of age.
Prevalence of P falciparum parasitaemia and overall and severe anaemia at 12 months of age.
Proportion of humoral responses and geometric mean antibody titres of polio, DTP and Hepatitis B at 5 months and of measles at 9 and 12 months
Incidence of side effects in each group up to 12 months of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 2002
- Study completionDec 2005
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.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,498 participants
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Investigators
- Clara Menendez, MD, PhD, Principal investigator, Center for International Health, Hospital Clinic de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209794
- Sponsor's protocol ID
- TIM
- Status last verified
- Nov 2006
- First submitted
- 13 Sep 2005
- Last updated
- 16 Nov 2006
- Results posted
- No
Publications
Mayor A, Serra-Casas E, Sanz S, Aponte JJ, Macete E, Mandomando I, Puyol L, Berzosa P, Dobano C, Aide P, Sacarlal J, Benito A, Alonso P, Menendez C. Molecular markers of resistance to sulfadoxine-pyrimethamine during intermittent preventive treatment for malaria in Mozambican infants. J Infect Dis. 2008 Jun 15;197(12):1737-42. doi: 10.1086/588144.
PubMed 18419347
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children
- ClinicalTrials.gov ID
- NCT00209794
- Acronym / sponsor ID
- TIM
- Conditions
- Malaria
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,498 participants
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Sep 2002
- Study completion
- Dec 2005
- First posted
- 21 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.
To evaluate if intermittent preventive treatment in infants (IPTi) consisting of SP [Fansidar] given through the EPI scheme alongside routine immunisations at 3, 4 and 9 months of age reduces de incidence of clinical malaria up to 12 months of age
Detailed description
The study is a randomised, double blind, placebo-controlled trial of the antimalarial drug sulphadoxine-pyrimethamine administered intermittently at 3, 4 and 9 months of age through the EPI scheme at the time of routine immunisations.
Children will be randomized into placebo and SP treatment groups by block randomization, and it is expected a similar age distribution and a similar number of children in each group.
Doses of sulphadoxine (25 mg/kg)-pyrimethamine (1.25 mg/kg) (SP) or placebo will be given by a health assistant according to bodyweight (a quarter of a tablet for those <5kg, a half for those 5-10 kg, and a whole tablet for children >10 kg). The tablets will be crashed and diluted with water for their administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children from study area
- Signed informed consent
Key exclusion criteria (1 listed)
- History of drug allergies
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 (Fansidar) | Drug | – |
Primary outcome
Incidence of first or only malaria episodes in each study cohort by 12 months of age.
11 secondary outcomes
Incidence of first or only malaria episodes by group up to 12 months of age as per protocol analysis.
Incidence of first or only malaria episodes by group up to 24 months of age.
Incidence of multiple malaria episodes up to 12 months of age.
Incidence of multiple malaria episodes up to 24 months of age.
Incidence of overall and severe anaemia up to 12 months of age.
Incidence of overall and severe anaemia up to 24 months of age.
Proportion of humoral and cellular immune responses against malaria at 12 months of age.
Total number of admissions and outpatient attendances up to 24 months of age.
Prevalence of P falciparum parasitaemia and overall and severe anaemia at 12 months of age.
Proportion of humoral responses and geometric mean antibody titres of polio, DTP and Hepatitis B at 5 months and of measles at 9 and 12 months
Incidence of side effects in each group up to 12 months of age.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2006.
- Derived from this study: PubMed 18419347Mayor A, Serra-Casas E, Sanz S, Aponte JJ, Macete E, Mandomando I, Puyol L, Berzosa P, Dobano C, Aide P, Sacarlal J, Benito A, Alonso P, Menendez C. Molecular markers of resistance to sulfadoxine-pyrimethamine during intermittent preventive treatment for malaria in Mozambican infants. J Infect Dis. 2008 Jun 15;197(12):1737-42. doi: 10.1086/588144.
- Related InfoLink 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.
Clara Menendez, MD, PhD principal investigator
Center for International Health, Hospital Clinic de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sulfadoxine-Pyrimethamine (Fansidar) in people with Malaria, run by Hospital Clinic of Barcelona at 1 site in Mozambique.
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 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 16 Nov 2006. 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 Mozambique. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of first or only malaria episodes in each study cohort by 12 months of age.. 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 NCT00209794, 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 16 Nov 2006.