Acute Non-falciparum MalariaNCT00725777
Treatment of Non-falciparum Malaria
A study testing artemether-lumefantrine in people with Acute Non-falciparum Malaria, run by Albert Schweitzer Hospital at 1 site in Gabon.
Trial summary
Patients with non-falciparum infection will be given artemether-lumefantrine for three days and will be followed up for 28 days. Besides efficacy and safety evaluations a substudy on immunology will be performed. Read more about this study
- Who is it for?
- Ages 6 months to 60 years
- Conditions the study is for
- Acute Non-falciparum Malaria
- What is being tested?
- artemether-lumefantrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGabon
- Study dates
- Jul 2008to Feb 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female patients between the age of 6 months and 60 years and with a minimum of 5kg bodyweight
- Presence of uncomplicated malaria confirmed by: i)fever or history of fever in the previous 4 days, and ii)positive microscopy of P. malariae or P. ovale or mixed infection with P.falciparum with parasite density > 50-200000/μl of blood
- Written informed consent
Who cannot join
- Patients with presence of other clinical conditions requiring hospitalization
- Presence of other febrile conditions
- Presence of significant anemia, defined by hemoglobin < 7g/dl
- Known history of hypersensitivity,allergic or adverse reactions to artemether or lumefantrine
- Intake of any antimalarial or antibiotics with known antimalarial activity in the preceding 2 weeks
- Pregnant and breast feeding females
Trial locations and contacts
1 site in 1 country.
Gabon1 site
Medical Research Unit of the Albert Schweitzer Hospital
Lambaréné, Moyen-Ogooué Province, BP 118
About this study
Official title: Efficacy and Safety of Artemether Lumefantrine Combination Therapy for the Treatment of Malaria Due to Plasmodium Ovale, Plasmodium Malariae, and Mixed Plasmodium Infections in Gabon
Patients with non-falciparum infection will be given artemether-lumefantrine for three days and will be followed up for 28 days. Besides efficacy and safety evaluations a substudy on immunology will be performed.
- Conditions
- Acute Non-falciparum Malaria
- Being tested
- artemether-lumefantrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artemether-lumefantrineDrug
Standard artemether-lumefantrine treatment
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: artemether-lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasitological cure rate on day 28
Measured: D28
Secondary outcomes (1)
Frequency and severity of drug related adverse events
Measured: D28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2011
- Study completionFeb 2012
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 Acute Non-falciparum 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Schweitzer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Ramharter, Albert Schweitzer Hospital
- Investigators
- Sabine Bélard, MD, Principal investigator, Medical Research Unit of the Albert Schweitzer Hospital in Lambaréné
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725777
- Sponsor's protocol ID
- IDC-08-01
- Status last verified
- Feb 2012
- First submitted
- 14 Jul 2008
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Mombo-Ngoma G, Kleine C, Basra A, Wurbel H, Diop DA, Capan M, Adegnika AA, Kurth F, Mordmuller B, Joanny F, Kremsner PG, Ramharter M, Belard S. Prospective evaluation of artemether-lumefantrine for the treatment of non-falciparum and mixed-species malaria in Gabon. Malar J. 2012 Jul 10;11:120. doi: 10.1186/1475-2875-11-120.
PubMed 22515681
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Artemether Lumefantrine Combination Therapy for the Treatment of Malaria Due to Plasmodium Ovale, Plasmodium Malariae, and Mixed Plasmodium Infections in Gabon
- ClinicalTrials.gov ID
- NCT00725777
- Acronym / sponsor ID
- IDC-08-01
- Conditions
- Acute Non-falciparum Malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Albert Schweitzer HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 30 Jul 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.
Patients with non-falciparum infection will be given artemether-lumefantrine for three days and will be followed up for 28 days. Besides efficacy and safety evaluations a substudy on immunology will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: artemether-lumefantrine |
Who may qualify
- Ages
- 6 months to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female patients between the age of 6 months and 60 years and with a minimum of 5kg bodyweight
- Presence of uncomplicated malaria confirmed by: i)fever or history of fever in the previous 4 days, and ii)positive microscopy of P. malariae or P. ovale or mixed infection with P.falciparum with parasite density > 50-200000/μl of blood
- Written informed consent
Key exclusion criteria (6 listed)
- Patients with presence of other clinical conditions requiring hospitalization
- Presence of other febrile conditions
- Presence of significant anemia, defined by hemoglobin < 7g/dl
- Known history of hypersensitivity,allergic or adverse reactions to artemether or lumefantrine
- Intake of any antimalarial or antibiotics with known antimalarial activity in the preceding 2 weeks
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 |
|---|---|---|
| artemether-lumefantrineStandard artemether-lumefantrine treatment | Drug | A |
Primary outcome
Parasitological cure rate on day 28
Time frame: D28
1 secondary outcome
Frequency and severity of drug related adverse events
Time frame: D28
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 17 Feb 2012.
- Derived from this study: PubMed 22515681Mombo-Ngoma G, Kleine C, Basra A, Wurbel H, Diop DA, Capan M, Adegnika AA, Kurth F, Mordmuller B, Joanny F, Kremsner PG, Ramharter M, Belard S. Prospective evaluation of artemether-lumefantrine for the treatment of non-falciparum and mixed-species malaria in Gabon. Malar J. 2012 Jul 10;11:120. doi: 10.1186/1475-2875-11-120.
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.
Sabine Bélard, MD principal investigator
Medical Research Unit of the Albert Schweitzer Hospital in Lambaréné
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing artemether-lumefantrine in people with Acute Non-falciparum Malaria, run by Albert Schweitzer Hospital 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 3 inclusion and 6 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 17 Feb 2012. 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.
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?
Parasitological cure rate on day 28 (time frame: D28). 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 NCT00725777, 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 17 Feb 2012.