Plasmodium Falciparum MalariaNCT00304980
Comparative Evaluation of the Safety and the Efficacy of 2 Antimalarials Depending on HIV Status
A study testing ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE in people with Plasmodium Falciparum Malaria, run by Institute of Tropical Medicine, Belgium at 1 site in Zambia.
Trial summary
The purpose of this study is to determine the safety and efficacy of sulfadoxine-pyrimethamine (SP) versus artemether-lumefantrine (Coartem) when administered to HIV+ and HIV- patients with uncomplicated P. falciparum malaria. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Plasmodium Falciparum Malaria
- What is being tested?
- ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE
- How many people
- 3,000 participants
- Where
- 1 siteZambia
- Study dates
- Mar 2003to Apr 2005
- 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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Man and non-pregnant women aged between 15 and 50.
- P.falciparum mono-infection of at least 1,000 parasites/µl.
- Body temperature ≥ 37.5°C at the moment of enrolment or history of fever in the preceding 48 hrs.
- Consent from patient obtained.
Who cannot join
- Pregnancy.
- Severe P. falciparum malaria .
- Documented intake of SP or Coartem two weeks or less prior recruitment.
- Other cause(s) of fever.
- Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition).
- History of allergy to study drug, or known allergy to other Sulphur drugs such as co-trimoxazol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of the Safety and the Efficacy of Artemether + Lumefantrine (Coartem™) vs. Sulfadoxine + Pyrimethamine (SP) in Both HIV+ and HIV- Adults With Uncomplicated P. Falciparum Malaria in Zambia
The purpose of this study is to determine the safety and efficacy of sulfadoxine-pyrimethamine (SP) versus artemether-lumefantrine (Coartem) when administered to HIV+ and HIV- patients with uncomplicated P. falciparum malaria. Patients will be randomised to one of the 2 treatment and followed up (until day 14 actively) for 45 days.
- Conditions
- Plasmodium Falciparum Malaria
- Being tested
- ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINEDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR corrected clinical and parasitological outcome at day 45
Secondary outcomes (2)
Tolerability
Clinical recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2006 (estimated)
- Study startMar 2003
- Study completionApr 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 Plasmodium 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Investigators
- Umberto D'Alessandro, MD,MSc, PHD, Principal investigator, Institute of Tropical Medicine Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304980
- Sponsor's protocol ID
- 02 52 5 406
- Status last verified
- Sep 2010
- First submitted
- 20 Mar 2006
- Last updated
- 14 Sep 2010
- Results posted
- No
Publications
Van Geertruyden JP, Mulenga M, Mwananyanda L, Chalwe V, Moerman F, Chilengi R, Kasongo W, Van Overmeir C, Dujardin JC, Colebunders R, Kestens L, D'Alessandro U. HIV-1 immune suppression and antimalarial treatment outcome in Zambian adults with uncomplicated malaria. J Infect Dis. 2006 Oct 1;194(7):917-25. doi: 10.1086/507310. Epub 2006 Aug 29.
PubMed 16960779
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Safety and the Efficacy of Artemether + Lumefantrine (Coartem™) vs. Sulfadoxine + Pyrimethamine (SP) in Both HIV+ and HIV- Adults With Uncomplicated P. Falciparum Malaria in Zambia
- ClinicalTrials.gov ID
- NCT00304980
- Acronym / sponsor ID
- 02 52 5 406
- Conditions
- Plasmodium Falciparum Malaria
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3,000 participants
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Study start
- Mar 2003
- Study completion
- Apr 2005
- First posted
- 21 Mar 2006 (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 purpose of this study is to determine the safety and efficacy of sulfadoxine-pyrimethamine (SP) versus artemether-lumefantrine (Coartem) when administered to HIV+ and HIV- patients with uncomplicated P. falciparum malaria. Patients will be randomised to one of the 2 treatment and followed up (until day 14 actively) for 45 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Man and non-pregnant women aged between 15 and 50.
- P.falciparum mono-infection of at least 1,000 parasites/µl.
- Body temperature ≥ 37.5°C at the moment of enrolment or history of fever in the preceding 48 hrs.
- Consent from patient obtained.
Key exclusion criteria (6 listed)
- Pregnancy.
- Severe P. falciparum malaria .
- Documented intake of SP or Coartem two weeks or less prior recruitment.
- Other cause(s) of fever.
- Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition).
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 + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE | Drug | – |
Primary outcome
PCR corrected clinical and parasitological outcome at day 45
2 secondary outcomes
Tolerability
Clinical recovery
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2010.
- Results publication: PubMed 16960779Van Geertruyden JP, Mulenga M, Mwananyanda L, Chalwe V, Moerman F, Chilengi R, Kasongo W, Van Overmeir C, Dujardin JC, Colebunders R, Kestens L, D'Alessandro U. HIV-1 immune suppression and antimalarial treatment outcome in Zambian adults with uncomplicated malaria. J Infect Dis. 2006 Oct 1;194(7):917-25. doi: 10.1086/507310. Epub 2006 Aug 29.
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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.
Umberto D'Alessandro, MD,MSc, PHD principal investigator
Institute of Tropical Medicine Antwerp
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 VS. SULFADOXINE + PYRIMETHAMINE in people with Plasmodium Falciparum Malaria, run by Institute of Tropical Medicine, Belgium at 1 site in Zambia.
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 4 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: stopped early, as of the sponsor's last update on 14 Sep 2010. 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 Zambia. 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 was stopped early. 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?
PCR corrected clinical and parasitological outcome at day 45. 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 NCT00304980, 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 14 Sep 2010.