MalariaPhase 4NCT00386750
Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function
A Phase 4 study testing Artemether-lumefantrine in people with Malaria and Falciparum, run by Novartis Pharmaceuticals.
Trial summary
THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA. To evaluate the effects of artemether/ lumefantrine on the auditory function. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Artemether-lumefantrine
- How many people
- 265 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Nov 2005
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12 years of age or older
- P. falciparum parasitemia between 50 and 100,000 parasites/μl
- History of fever or presence of fever (temperature ≥ 37.5°C)
Who cannot join
- Signs/symptoms of severe/complicated malaria
- Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2 months
- History of any drug-related hearing impairment.
- Abnormal hearing function at study entry
- Exposure to sustained loud noises, by self-report, within the past 24 hours. -- Present ear problems
- (Other protocol-defined inclusion/exclusion criteria may apply.)
About this study
Official title: An Open-label, Single-center Study of the Effects of Co-artemether, Atovaquone-proguanil, and Artesunate-mefloquine on Auditory Function Following the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Patients 12 Years of Age or Older.
THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.
To evaluate the effects of artemether/ lumefantrine on the auditory function.
- Conditions
- Malaria, Falciparum
- Being tested
- Artemether-lumefantrine
- Keywords
- Malaria, hearing, co-artemether, auditory, Plasmodium falciparum, marsh fever, Plasmodium infections, remittent fever, paludism, artemether, artemisinins, benflumetol, lumefantrine
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).
Secondary outcomes (3)
Rate of auditory changes following 3 days of treatment with artemether-lumefantrine at Days 7, 28, and 42 days assessed by pure tone thresholds assessments (a type of hearing test)
Changes in auditory function with a non-ACT (artemisinin combined therapy) antimalarial (Malarone, atovaquone-proguanil) and another ACT combination (artesunate-mefloquine) assessed by pure tone thresholds (a type of hearing test)
Relationship between changes in auditory function and drug exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startJun 2005
- Primary completionNov 2005
- Study completionNov 2005
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.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386750
- Sponsor's protocol ID
- CCOA566A2412
- Status last verified
- Apr 2012
- First submitted
- 11 Oct 2006
- Last updated
- 27 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-center Study of the Effects of Co-artemether, Atovaquone-proguanil, and Artesunate-mefloquine on Auditory Function Following the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Patients 12 Years of Age or Older.
- ClinicalTrials.gov ID
- NCT00386750
- Acronym / sponsor ID
- CCOA566A2412
- Conditions
- Malaria, Falciparum
- Keywords
- Malaria, hearing, co-artemether, auditory, Plasmodium falciparum, marsh fever, Plasmodium infections, remittent fever
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 265 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 12 Oct 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.
THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.
To evaluate the effects of artemether/ lumefantrine on the auditory function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 12 years of age or older
- P. falciparum parasitemia between 50 and 100,000 parasites/μl
- History of fever or presence of fever (temperature ≥ 37.5°C)
Key exclusion criteria (6 listed)
- Signs/symptoms of severe/complicated malaria
- Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2 months
- History of any drug-related hearing impairment.
- Abnormal hearing function at study entry
- Exposure to sustained loud noises, by self-report, within the past 24 hours. -- Present ear problems
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 | Drug | – |
Primary outcome
Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).
3 secondary outcomes
Rate of auditory changes following 3 days of treatment with artemether-lumefantrine at Days 7, 28, and 42 days assessed by pure tone thresholds assessments (a type of hearing test)
Changes in auditory function with a non-ACT (artemisinin combined therapy) antimalarial (Malarone, atovaquone-proguanil) and another ACT combination (artesunate-mefloquine) assessed by pure tone thresholds (a type of hearing test)
Relationship between changes in auditory function and drug exposure.
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 27 Apr 2012.
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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.
Novartis Pharmaceuticals study chair
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Artemether-lumefantrine in people with Malaria and Falciparum, run by Novartis Pharmaceuticals.
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: stopped early, as of the sponsor's last update on 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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. 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?
Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).. 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 27 Apr 2012.