MalariaNCT01133314
Artemether-Lumefantrine Effectiveness in Guinea-Bissau 2
An observational study of Malaria, run by Bandim Health Project at 1 site in Guinea-Bissau.
Trial summary
The routine treatment of children with antimalarials will be monitored. Children with a positive malaria film and/or a positive rapid diagnostic test (RDT) will have a capillary blood sample taken to verify the diagnosis and to monitor the pattern of resistance. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Malaria
- How many people
- 600 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- May 2010to Jul 2016
- Phase
- Observational
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children seeking a health centre and by the health staff given the diagnosis: malaria and/or being treated with an antimalarial.
Who may be able to join
- Children seeking a health centre and by the health staff given the diagnosis: malaria and/or being treated with an antimalarial.
Who cannot join
- Children where the parents do not accept to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Bissau - 2
The routine treatment of children with antimalarials will be monitored. Children with a positive malaria film and/or a positive rapid diagnostic test (RDT) will have a capillary blood sample taken to verify the diagnosis and to monitor the pattern of resistance.
Read the detailed description
Children from Bissau seeking medical advice and who are recommended treatment for malaria in accordance with the current routines will be included as follows:
All children getting the clinical diagnosis of malaria will be registered and basic information collected.
All children with a positive malaria film and/or a positive RDT will be asked for a capillary blood sample (app. 50 - 100 microliters on a filterpaper). Using PCR the parasitological diagnosis will be verified and if parasites are identified the resistance patterns will be examined. Both the capillary blood samples and the RDTs (if taken by the health staff) will be used in order to examine whether the RDTs can be used for routine monitoring of resistance in an area.
The study does not interfere in the routine treatment of the health staff. None of the children will be followed.
- Conditions
- Malaria
- Medical subject headings
- Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children treated for malaria with a parasitological confirmed malaria.
The blood samples will be analysed for parasites at the end of the study. The results do not have any impact on the treatment of the children.
Measured: 6 weeks
Secondary outcomes (1)
Percentage of the parasites with mutations coding for resistance to antimalarials.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2012
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Poul-Erik Kofoed, MD, Ph.d., Principal investigator, Bandim Health Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133314
- Sponsor's protocol ID
- AL-eff 2010-2
- Status last verified
- Aug 2015
- First submitted
- 24 May 2010
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Bissau - 2
- ClinicalTrials.gov ID
- NCT01133314
- Acronym / sponsor ID
- AL-eff 2010-2
- Conditions
- Malaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 May 2010 (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 routine treatment of children with antimalarials will be monitored. Children with a positive malaria film and/or a positive rapid diagnostic test (RDT) will have a capillary blood sample taken to verify the diagnosis and to monitor the pattern of resistance.
Detailed description
Children from Bissau seeking medical advice and who are recommended treatment for malaria in accordance with the current routines will be included as follows:
All children getting the clinical diagnosis of malaria will be registered and basic information collected.
All children with a positive malaria film and/or a positive RDT will be asked for a capillary blood sample (app. 50 - 100 microliters on a filterpaper). Using PCR the parasitological diagnosis will be verified and if parasites are identified the resistance patterns will be examined. Both the capillary blood samples and the RDTs (if taken by the health staff) will be used in order to examine whether the RDTs can be used for routine monitoring of resistance in an area.
The study does not interfere in the routine treatment of the health staff. None of the children will be followed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children seeking a health centre and by the health staff given the diagnosis: malaria and/or being treated with an antimalarial.
Key inclusion criteria (1 listed)
- Children seeking a health centre and by the health staff given the diagnosis: malaria and/or being treated with an antimalarial.
Key exclusion criteria (1 listed)
- Children where the parents do not accept to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of children treated for malaria with a parasitological confirmed malaria.
Time frame: 6 weeks
The blood samples will be analysed for parasites at the end of the study. The results do not have any impact on the treatment of the children.
1 secondary outcome
Percentage of the parasites with mutations coding for resistance to antimalarials.
Time frame: 2 years
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 26 May 2021.
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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.
Poul-Erik Kofoed, MD, Ph.d. principal investigator
Bandim Health Project
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Bandim Health Project at 1 site in Guinea-Bissau.
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: finished, as of the sponsor's last update on 26 May 2021. 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 Guinea-Bissau. 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?
Percentage of children treated for malaria with a parasitological confirmed malaria. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2021.