MalariaPhase 4NCT00451139
Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials
A Phase 4 study testing artemether/lumefantrine, quinine and atovaquone/proguanil in people with Malaria, run by Jimma University at 1 site in Ethiopia.
Trial summary
The purpose of the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Malaria
- What is being tested?
- artemether/lumefantrine, quinine and atovaquone/proguanil
- How many people
- Not given
- Where
- 1 siteEthiopia
- Study dates
- Start not givento not given
- 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 5 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients aged above 5 years
- Uncomplicated falciparum malaria
- Axillary Temperature ≥37,5°C or history of fever within the previous 24 hours
- Ability to tolerate oral therapy
- Informed consent by the patient or by parent/guardian for children
- Residence in study area
Who cannot join
- Known or suspected hearing deficits
- Adequate anti-malarial treatment within the previous 7 days
- Mixed infection
- Danger signs and signs of severe malaria as defined by the WHO
- Presence of severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
- Concomitant disease masking assessment of response
- History of allergy or intolerance against study medications
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function.
Read the detailed description
Artemisinin based combination therapies (ACT) currently are the most promising treatment options for uncomplicated falciparum malaria. There have been controversial reports about possible ototoxicity of artemether / lumefantrine (Coartem®) from retrospective studies. In this investigation treatment of uncomplicated malaria with artemether / lumefantrine, quinine, where side-effects on hearing are known, or atovaquone / proguanil, where no such effects have been reported, are compared. Auditoy function is examined (Auditory Brainstem Response, Pure-tone Audiometry, Otoacustic Emissions) before treatment, after 7, 28, and, for determination of irreversibility, after 90 days.
- Conditions
- Malaria
- Being tested
- artemether/lumefantrine, quinine, atovaquone/proguanil
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artemether/lumefantrineDrug
quinineDrug
atovaquone/proguanilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
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
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Investigators
- Nebreed Fesseaha, MD, Dean, Study chair, Facuty of Medical Sciences Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451139
- Sponsor's protocol ID
- AITM0107
- Status last verified
- Mar 2007
- First submitted
- 21 Mar 2007
- Last updated
- 23 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials
- ClinicalTrials.gov ID
- NCT00451139
- Acronym / sponsor ID
- AITM0107
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- First posted
- 23 Mar 2007 (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 the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function.
Detailed description
Artemisinin based combination therapies (ACT) currently are the most promising treatment options for uncomplicated falciparum malaria. There have been controversial reports about possible ototoxicity of artemether / lumefantrine (Coartem®) from retrospective studies. In this investigation treatment of uncomplicated malaria with artemether / lumefantrine, quinine, where side-effects on hearing are known, or atovaquone / proguanil, where no such effects have been reported, are compared. Auditoy function is examined (Auditory Brainstem Response, Pure-tone Audiometry, Otoacustic Emissions) before treatment, after 7, 28, and, for determination of irreversibility, after 90 days.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged above 5 years
- Uncomplicated falciparum malaria
- Axillary Temperature ≥37,5°C or history of fever within the previous 24 hours
- Ability to tolerate oral therapy
- Informed consent by the patient or by parent/guardian for children
Key exclusion criteria (8 listed)
- Known or suspected hearing deficits
- Adequate anti-malarial treatment within the previous 7 days
- Mixed infection
- Danger signs and signs of severe malaria as defined by the WHO
- Presence of severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
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 | – |
| quinine | Drug | – |
| atovaquone/proguanil | Drug | – |
Primary outcome
Not reported in the source record.
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 23 Mar 2007.
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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.
Nebreed Fesseaha, MD, Dean study chair
Facuty of Medical Sciences Jimma University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing artemether/lumefantrine, quinine and atovaquone/proguanil in people with Malaria, run by Jimma University at 1 site in Ethiopia.
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 6 inclusion and 8 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 23 Mar 2007. 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 Ethiopia. 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.
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 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.
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 23 Mar 2007.