Falciparum MalariaPhase 2NCT01374126
Azithromycin Combination Therapy for the Treatment of Severe Malaria
A Phase 2 study testing Artesunate and Azithromycin + Artesunate in people with Falciparum Malaria, run by Medical University of Vienna at 1 site in Bangladesh.
Trial summary
A randomized controlled trial to assess the safety and efficacy of azithromycin combination therapy for use in severe malaria. This pilot trial will be conducted in uncomplicated malaria patients in southeastern Bangladesh. Read more about this study
- Who is it for?
- Ages 8 to 65 years
- Conditions the study is for
- Falciparum Malaria
- What is being tested?
- Artesunate and Azithromycin + Artesunate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteBangladesh
- Study dates
- Jul 2011to Nov 2012
- Phase
- Phase 2
- 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 8 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female participants with a diagnosis of acute falciparum malaria meeting all criteria listed below may be included in the study:
- Acute symptomatic falciparum malaria infection with a parasite density of 100 to 100,000 asexual parasites/uL as determined on the screening smear with fever (defined as ≥37.5ºC), or reported history of fever within the last 48 hours.
- Age: 8-65 years old
- Males or females. All females over the age of 12 are required to have a negative human chorionic gonadotropin (hCG) pregnancy test (urine). All females of childbearing potential (not surgically sterile, or less than two years menopausal) are required to use an acceptable method of contraception, such as implant, injectable, oral contraceptive(s) with additional barrier contraception, intrauterine device, sexual abstinence, or vasectomized partner, throughout the study
- Written informed consent obtained
- Willing to stay under close medical supervision for the study duration
- Otherwise healthy outpatients
Who cannot join
- Participants presenting with any of the following will not be included in the study:
- Pregnant women, nursing mothers, or women of childbearing potential who do not use an acceptable method of contraception (as described in Inclusion Criteria, #3)
- Mixed malaria infection on admission by malaria smear
- A previous history of intolerance or hypersensitivity to the study drugs artesunate, azithromycin or to drugs with similar chemical structures
- Malaria drug therapy administered in the past 30 days by history
- History of significant cardiovascular, liver or renal functional abnormality or any other clinically significant illness, which in the opinion of the investigator would place them at increased risk.
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- Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
- Signs or symptoms of severe malaria (as defined by WHO 2003)
- Unable and/or unlikely to comprehend and/or follow the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Azithromycin Combination Therapy for the Treatment of Severe Malaria - A Pilot Safety and Efficacy Study in Uncomplicated Falciparum Malaria in Bangladesh
A randomized controlled trial to assess the safety and efficacy of azithromycin combination therapy for use in severe malaria. This pilot trial will be conducted in uncomplicated malaria patients in southeastern Bangladesh.
- Conditions
- Falciparum Malaria
- Being tested
- Artesunate, Azithromycin + Artesunate
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtesunateDrug
Artesunate alone
Azithromycin + ArtesunateDrug
Combination of azithromycin + artesunate
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin-Artesunate | Experimental | Not described Receives: Drug: Azithromycin + Artesunate |
| Control (artesunate alone) | Active comparator | Not described Receives: Drug: Artesunate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability (Number of Participants with Adverse Events)
Measured: 42 days
Adequate Clinical and Parasitological Response (ACPR) on Days 28 and 42
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falciparum MalariaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Principal investigator, Harald Noedl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374126
- Sponsor's protocol ID
- PR-11019
- Status last verified
- Aug 2013
- First submitted
- 10 Jun 2011
- Last updated
- 23 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin Combination Therapy for the Treatment of Severe Malaria - A Pilot Safety and Efficacy Study in Uncomplicated Falciparum Malaria in Bangladesh
- ClinicalTrials.gov ID
- NCT01374126
- Acronym / sponsor ID
- PR-11019
- Conditions
- Falciparum Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Jul 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 15 Jun 2011 (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.
A randomized controlled trial to assess the safety and efficacy of azithromycin combination therapy for use in severe malaria. This pilot trial will be conducted in uncomplicated malaria patients in southeastern Bangladesh.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin-Artesunate | Experimental | Drug: Azithromycin + Artesunate |
| Control (artesunate alone) | Active comparator | Drug: Artesunate |
Who may qualify
- Ages
- 8 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female participants with a diagnosis of acute falciparum malaria meeting all criteria listed below may be included in the study:
- Acute symptomatic falciparum malaria infection with a parasite density of 100 to 100,000 asexual parasites/uL as determined on the screening smear with fever (defined as ≥37.5ºC), or reported history of fever within the last 48 hours.
- Age: 8-65 years old
- Males or females. All females over the age of 12 are required to have a negative human chorionic gonadotropin (hCG) pregnancy test (urine). All females of childbearing potential (not surgically sterile, or less than two years menopausal) are required to use an acceptable method of contraception, such as implant, injectable, oral contraceptive(s) with additional barrier contraception, intrauterine device, sexual abstinence, or vasectomized partner, throughout the study
- Written informed consent obtained
Key exclusion criteria (9 listed)
- Pregnant women, nursing mothers, or women of childbearing potential who do not use an acceptable method of contraception (as described in Inclusion Criteria, #3)
- Mixed malaria infection on admission by malaria smear
- A previous history of intolerance or hypersensitivity to the study drugs artesunate, azithromycin or to drugs with similar chemical structures
- Malaria drug therapy administered in the past 30 days by history
- History of significant cardiovascular, liver or renal functional abnormality or any other clinically significant illness, which in the opinion of the investigator would place them at increased risk.
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 |
|---|---|---|
| ArtesunateArtesunate alone | Drug | Control (artesunate alone) |
| Azithromycin + ArtesunateCombination of azithromycin + artesunate | Drug | Azithromycin-Artesunate |
Primary outcome
Safety and Tolerability (Number of Participants with Adverse Events)
Time frame: 42 days
Adequate Clinical and Parasitological Response (ACPR) on Days 28 and 42
Time frame: 42 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 23 Aug 2013.
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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.
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?
A Phase 2 study testing Artesunate and Azithromycin + Artesunate in people with Falciparum Malaria, run by Medical University of Vienna at 1 site in Bangladesh.
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 7 inclusion and 9 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 Aug 2013. 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 Bangladesh. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Safety and Tolerability (Number of Participants with Adverse Events) (time frame: 42 days). The study lists 2 primary outcomes in all. 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 23 Aug 2013.