MalariaPhase 4NCT00453856
Efficacy of Sulfadoxine-Pyrimethamine for Treating Malaria in Gabonese Children
A Phase 4 study testing Sulfadoxine Pyrimethamine in people with Malaria, run by Albert Schweitzer Hospital, Netherlands at 1 site in Gabon.
Trial summary
IPTi, a strategy whereby infants are provided treatment doses of antimalarials at routine vaccination visits, has been shown to significantly reduce malaria and anemia in two studies in Tanzania. However the results obtained in Gabon are not similar. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria
- What is being tested?
- Sulfadoxine Pyrimethamine
- How many people
- 139 participants
- Where
- 1 siteGabon
- Study dates
- Mar 2007to not given
- Phase
- Phase 4
- 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 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female outpatients
- Aged 6 to 59 months
- Body weight between 7.5 to 30 kg
- uncomplicated falciparum malaria with parasitaemia between 1,000/µL and 200,000/µL
- Ability to tolerate oral therapy
- Informed consent, oral agreement of the child if appropriate
Who cannot join
- Still in IPTi trial and/or still in any other intervention trial
- Known G6PD-deficiency
- Presence of severe malnutrition
- Inability to drink or breastfeed
- Recent history of convulsions, lethargy or unconsciousness;
- Signs of severe and complicated
Show all 10Show fewer
- Mixed/mono infection that includes a non-P. falciparum species.
- Hb < 7g/dl
- Inability to attend stipulated follow-up visits.
- History of hypersensitivity reactions to the drug being evaluated
Trial locations and contacts
1 site in 1 country.
Gabon1 site
Medical Research Unit of the Albert Schweitzer Hospital
Lambaréné, Moyen-Ogooué Province, B.P. 118
About this study
Official title: Efficacy of Sulfadoxine-Pyrimethamine in the Treatment of Symptomatic, Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children in Lambaréné
IPTi, a strategy whereby infants are provided treatment doses of antimalarials at routine vaccination visits, has been shown to significantly reduce malaria and anemia in two studies in Tanzania. However the results obtained in Gabon are not similar. Many factors are likely to influence the efficacy or effectiveness IPTi. It is reasonable to assume that the efficacy of IPTi will be influenced markedly by the sensitivity of Plasmodium falciparum to the antimalarial drug (Sulfadoxine-Pyrimethamine) used for IPTi.
In order to interpret the results of individual IPTi trials conducted by the IPTi Consortium, and to provide information for policy makers regarding the predicted efficacy of IPTi, it is essential to obtain information on antimalarial drug sensitivity of Sulfadoxine-Pyrimethamine now that the IPTi trial has been conducted. The simplest and most universally accepted measure of testing for antimalarial drug efficacy is the "in vivo efficacy study," which follows a standardized World Health Organization protocol.
Read more
A second reason for evaluating drug resistance as an adjunct to the IPTi trials is to determine if the intervention increases the carriage and/or spread of drug resistant P. falciparum parasites.
Thirdly the overall effect at the community level of selection of resistant genotypes in IPTi-recipients is unclear.
Read the detailed description
Administration of standard single oral dose of sulfadoxine-pyrimethamine to children aged 6-59 month old children in Lambaréné at enrolment, if eligible according to the approved protocol.
139 subjects will be enrolled and treated with Sulfadoxine-Pyrimethamine for uncomplicated malaria. Thereafter each subject will be followed according to the approved protocol
The proportion of subjects with Adequate Clinical and Parasitological response (ACPR) by day 28, Early Treatment Failure (ETF), Late Clinical Failure (LCF) and Late Parasitological Failure (LPF)will be evaluated.
secondly the frequency of molecular markers for Sulfadoxine-Pyrimethamine drug resistance will be determined.
- Conditions
- Malaria
- Being tested
- Sulfadoxine Pyrimethamine
- Keywords
- Malaria, Sulfadoxine, Pyrimethamine, Resistance, Gabon
- 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.
Measure the clinical and parasitological efficacy of SP among patients aged between 6-59 months suffering from uncomplicated P falciparum malaria,
Secondary outcomes (1)
Determine the frequency of molecular markers for drug resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startMar 2007
Why it stopped: The study was terminated because of Early Treatment Failure in child.The justification for this decision are concerns about safety of children.
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Schweitzer Hospital, Netherlands
- Collaborators
- Albert Schweitzer Hospital, Bill and Melinda Gates Foundation
- Investigators
- Martin P Grobusch, MD, Study director, Medical Research Unit, Albert Schweitzer Hospital LambarénéSaadou Issifou, MD MSc, Principal investigator, Albert Schweitzer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453856
- Sponsor's protocol ID
- IPTi-DRWG- SP Lambaréné
- Status last verified
- Aug 2007
- First submitted
- 28 Mar 2007
- Last updated
- 10 Aug 2007
- Results posted
- No
Publications
Mombo-Ngoma G, Oyakhirome S, Ord R, Gabor JJ, Greutelaers KC, Profanter K, Greutelaers B, Kurth F, Lell B, Kun JF, Issifou S, Roper C, Kremsner PG, Grobusch MP. High prevalence of dhfr triple mutant and correlation with high rates of sulphadoxine-pyrimethamine treatment failures in vivo in Gabonese children. Malar J. 2011 May 14;10:123. doi: 10.1186/1475-2875-10-123.
PubMed 21569596
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sulfadoxine-Pyrimethamine in the Treatment of Symptomatic, Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children in Lambaréné
- ClinicalTrials.gov ID
- NCT00453856
- Acronym / sponsor ID
- IPTi-DRWG- SP Lambaréné
- Conditions
- Malaria
- Keywords
- Malaria, Sulfadoxine, Pyrimethamine, Resistance, Gabon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because of Early Treatment Failure in child.The justification for this decision are concerns about safety of children.
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Albert Schweitzer Hospital, Netherlands
- Collaborators
- Albert Schweitzer Hospital, Bill and Melinda Gates Foundation
- Study start
- Mar 2007
- First posted
- 29 Mar 2007 (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.
IPTi, a strategy whereby infants are provided treatment doses of antimalarials at routine vaccination visits, has been shown to significantly reduce malaria and anemia in two studies in Tanzania. However the results obtained in Gabon are not similar. Many factors are likely to influence the efficacy or effectiveness IPTi. It is reasonable to assume that the efficacy of IPTi will be influenced markedly by the sensitivity of Plasmodium falciparum to the antimalarial drug (Sulfadoxine-Pyrimethamine) used for IPTi.
In order to interpret the results of individual IPTi trials conducted by the IPTi Consortium, and to provide information for policy makers regarding the predicted efficacy of IPTi, it is essential to obtain information on antimalarial drug sensitivity of Sulfadoxine-Pyrimethamine now that the IPTi trial has been conducted. The simplest and most universally accepted measure of testing for antimalarial drug efficacy is the "in vivo efficacy study," which follows a standardized World Health Organization protocol.
A second reason for evaluating drug resistance as an adjunct to the IPTi trials is to determine if the intervention increases the carriage and/or spread of drug resistant P. falciparum parasites.
Thirdly the overall effect at the community level of selection of resistant genotypes in IPTi-recipients is unclear.
Detailed description
Administration of standard single oral dose of sulfadoxine-pyrimethamine to children aged 6-59 month old children in Lambaréné at enrolment, if eligible according to the approved protocol.
139 subjects will be enrolled and treated with Sulfadoxine-Pyrimethamine for uncomplicated malaria. Thereafter each subject will be followed according to the approved protocol
The proportion of subjects with Adequate Clinical and Parasitological response (ACPR) by day 28, Early Treatment Failure (ETF), Late Clinical Failure (LCF) and Late Parasitological Failure (LPF)will be evaluated.
secondly the frequency of molecular markers for Sulfadoxine-Pyrimethamine drug resistance will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male and female outpatients
- Aged 6 to 59 months
- Body weight between 7.5 to 30 kg
- uncomplicated falciparum malaria with parasitaemia between 1,000/µL and 200,000/µL
- Ability to tolerate oral therapy
Key exclusion criteria (10 listed)
- Still in IPTi trial and/or still in any other intervention trial
- Known G6PD-deficiency
- Presence of severe malnutrition
- Inability to drink or breastfeed
- Recent history of convulsions, lethargy or unconsciousness;
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
Measure the clinical and parasitological efficacy of SP among patients aged between 6-59 months suffering from uncomplicated P falciparum malaria,
1 secondary outcome
Determine the frequency of molecular markers for drug resistance
Results and safety
The study was stopped early (reason given: The study was terminated because of Early Treatment Failure in child.The justification for this decision are concerns about safety of children.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2007.
- Derived from this study: PubMed 21569596Mombo-Ngoma G, Oyakhirome S, Ord R, Gabor JJ, Greutelaers KC, Profanter K, Greutelaers B, Kurth F, Lell B, Kun JF, Issifou S, Roper C, Kremsner PG, Grobusch MP. High prevalence of dhfr triple mutant and correlation with high rates of sulphadoxine-pyrimethamine treatment failures in vivo in Gabonese children. Malar J. 2011 May 14;10:123. doi: 10.1186/1475-2875-10-123.
- (Homepage of the Medical Research Unit, Lambaréné)Link 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.
Martin P Grobusch, MD study director
Medical Research Unit, Albert Schweitzer Hospital Lambaréné
Saadou Issifou, MD MSc principal investigator
Albert Schweitzer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sulfadoxine Pyrimethamine in people with Malaria, run by Albert Schweitzer Hospital, Netherlands at 1 site in Gabon.
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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 10 Aug 2007. 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 Gabon. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated because of Early Treatment Failure in child.The justification for this decision are concerns about safety of children.). 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?
Measure the clinical and parasitological efficacy of SP among patients aged between 6-59 months suffering from uncomplicated P falciparum malaria,. 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 NCT00453856, 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 10 Aug 2007.