MalariaNCT01157689
Artemether-Lumefantrine Effectiveness in Guinea-Bissau
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 be included in a follow-up study. The genetic basis of the parasites for developing resistance will be examined. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Malaria
- How many people
- 500 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- Mar 2010to Jun 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 diagnosed as having malaria at Bandim Health Center in Bissau. Of these all children with a positive malaria film and/or a positive rapid diagnostic test will be included in an observational follow-up study.
Who may be able to join
- Prescribed an anti-malarial at the Bandim Health Centre
- Having P. falciparum parasites in a thick film and/or a positive RDT
- The Bandim address is known (to enable follow up).
Who cannot join
- Children where the parents do not accept to participate in the study.
- Signs of severe malaria such as convulsion or severe anemia
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 at the Bandim Health Centre
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 be included in a follow-up study. The genetic basis of the parasites for developing resistance will be examined. In case of reappearance of parasites the child will be re-treated following the guidelines of the national malaria programme.
Read the detailed description
Children from the Bandim area in Bissau who are 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. Of theses, children fulfilling the inclusion criteria will be included in a follow-up study.
The children included in the follow-up part of the study will be visited on day 7, day 14, day 21, day 28, day 35 and day 42. At each visit the condition of the child will be evaluated, a questionnaire will be filled in and a malaria film and approximately 100 µl blood on filter-paper (for PCR analysis in case of re-parasitaemia) will be taken. Furthermore, on day seven 100 μl blood on filter-paper will be taken for drug-analysis.
Children with parasitaemia detected by only one of the following methods will be excluded from the final analyses of the effectiveness: 1) malaria film, 2) RDT, and 3) PCR.
If the parents do not ensure that the children get the correct medication resulting in a high rate of recrudescence and/or a low drug-concentration on day seven the policy of the National Malaria Programme should be re-evaluated. If the health staff do not follow the guidelines of the National Malaria Programme the reasons why should be elucidated in order to ensure a better adherence.
- Conditions
- Malaria
- Keywords
- malaria, children, Guinea-Bissau, artemether, lumefantrine, effectiveness
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Coartem, chloroquine, quinine | All children with a positive malaria test will included. Results will be subanalysed acording to treatment given by routine health staff. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACPR day 42
Malaria slides will be examined weekly during follow-up until day 42. The adequate clinical and parasitological cure rate will to calculated for day 42.
Measured: day 42
Secondary outcomes (1)
ACPR day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionJun 2016
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157689
- Sponsor's protocol ID
- AL-eff 2010
- Status last verified
- May 2021
- First submitted
- 6 Jul 2010
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Jovel IT, Kofoed PE, Rombo L, Rodrigues A, Ursing J. Temporal and seasonal changes of genetic polymorphisms associated with altered drug susceptibility to chloroquine, lumefantrine, and quinine in Guinea-Bissau between 2003 and 2012. Antimicrob Agents Chemother. 2015 Feb;59(2):872-9. doi: 10.1128/AAC.03554-14. Epub 2014 Nov 24.
PubMed 25421474
Study at a glance
From the registry record, last updated by the sponsor on 19 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 at the Bandim Health Centre
- ClinicalTrials.gov ID
- NCT01157689
- Acronym / sponsor ID
- AL-eff 2010
- Conditions
- Malaria
- Keywords
- malaria, children, Guinea-Bissau, artemether, lumefantrine, effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Study start
- Mar 2010 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Jul 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 be included in a follow-up study. The genetic basis of the parasites for developing resistance will be examined. In case of reappearance of parasites the child will be re-treated following the guidelines of the national malaria programme.
Detailed description
Children from the Bandim area in Bissau who are 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. Of theses, children fulfilling the inclusion criteria will be included in a follow-up study.
The children included in the follow-up part of the study will be visited on day 7, day 14, day 21, day 28, day 35 and day 42. At each visit the condition of the child will be evaluated, a questionnaire will be filled in and a malaria film and approximately 100 µl blood on filter-paper (for PCR analysis in case of re-parasitaemia) will be taken. Furthermore, on day seven 100 μl blood on filter-paper will be taken for drug-analysis.
Children with parasitaemia detected by only one of the following methods will be excluded from the final analyses of the effectiveness: 1) malaria film, 2) RDT, and 3) PCR.
If the parents do not ensure that the children get the correct medication resulting in a high rate of recrudescence and/or a low drug-concentration on day seven the policy of the National Malaria Programme should be re-evaluated. If the health staff do not follow the guidelines of the National Malaria Programme the reasons why should be elucidated in order to ensure a better adherence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coartem, chloroquine, quinine | – | –All children with a positive malaria test will included. Results will be subanalysed acording to treatment given by routine health staff. |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children diagnosed as having malaria at Bandim Health Center in Bissau. Of these all children with a positive malaria film and/or a positive rapid diagnostic test will be included in an observational follow-up study.
Key inclusion criteria (3 listed)
- Prescribed an anti-malarial at the Bandim Health Centre
- Having P. falciparum parasites in a thick film and/or a positive RDT
- The Bandim address is known (to enable follow up).
Key exclusion criteria (2 listed)
- Children where the parents do not accept to participate in the study.
- Signs of severe malaria such as convulsion or severe anemia
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
ACPR day 42
Time frame: day 42
Malaria slides will be examined weekly during follow-up until day 42. The adequate clinical and parasitological cure rate will to calculated for day 42.
1 secondary outcome
ACPR day 28
Time frame: 28 days
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 19 May 2021.
- Derived from this study: PubMed 25421474Jovel IT, Kofoed PE, Rombo L, Rodrigues A, Ursing J. Temporal and seasonal changes of genetic polymorphisms associated with altered drug susceptibility to chloroquine, lumefantrine, and quinine in Guinea-Bissau between 2003 and 2012. Antimicrob Agents Chemother. 2015 Feb;59(2):872-9. doi: 10.1128/AAC.03554-14. Epub 2014 Nov 24.
Related trials for Malaria
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Permethrin-Treated Baby Wraps for Malaria Prevention in Refugee Settings
Malaria (Plasmodium Falciparum), Malaria Incidence
Not yet recruitingObservational study
Factors Influencing Adoption of a Novel Malaria Treatment in Côte d'Ivoire, Ghana, and Rwanda
Malaria
RecruitingPhase 1
Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays
Malaria
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.
The record lists no contact. Use the official record to reach the sponsor.
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 3 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 19 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?
ACPR day 42 (time frame: day 42). 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 NCT01157689, 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 19 May 2021.