Uncomplicated Falciparum MalariaPhase 2NCT00356005
Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh
A Phase 2 study testing azithromycin plus artesunate and Artesunate in people with Uncomplicated Falciparum Malaria, run by Medical University of Vienna at 1 site in Bangladesh.
Trial summary
The purpose of this study is to investigate the efficacy of azithromycin combination therapy with artesunate for the treatment of uncomplicated falciparum malaria in Bangladesh. Read more about this study
- Who is it for?
- Ages 8 to 65 years
- Conditions the study is for
- Uncomplicated Falciparum Malaria
- What is being tested?
- azithromycin plus artesunate and Artesunate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteBangladesh
- Study dates
- Aug 2006to Aug 2007
- 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
- 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
- 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 lumefantrine or to drugs with similar chemical structures
- Malaria drug therapy administered in the past 30 days by history
- Previous participation in this trial, or participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study
- 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.
Show all 9Show fewer
- 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 Uncomplicated Falciparum Malaria in Bangladesh: An Open Label Randomized Controlled Trial
The purpose of this study is to investigate the efficacy of azithromycin combination therapy with artesunate for the treatment of uncomplicated falciparum malaria in Bangladesh.
Read the detailed description
In view of spreading antimalarial drug resistance there is an urgent need for new combination treatments for a disease that kills more than one million people every year. Azithromycin is a macrolide antibiotic that is particularly attractive due to its safety in children and experience with use in pregnancy. Recent trials suggest that azithromycin has a strong potential as an antimalarial. The purpose of this study is to investigate the efficacy of azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in Bangladesh.
- Conditions
- Uncomplicated Falciparum Malaria
- Being tested
- azithromycin plus artesunate, Artesunate
- Keywords
- falciparum malaria, therapy, azithromycin, artesunate, Coartem, Bangladesh
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycin plus artesunateDrug
ArtesunateDrug
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin + Artesunate | Experimental | Azithromycin + Artesunate treatment Receives: Drug: azithromycin plus artesunate |
| Artesunate | Active comparator | Artesunate treatment controls Receives: Drug: Artesunate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42.
Measured: 42 days
Secondary outcomes (1)
Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT).
Measured: 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionAug 2007
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 Uncomplicated 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
- 228 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, Armed Forces Research Institute of Medical Sciences, Thailand
- Responsible party
- Principal investigator, Harald Noedl, Medical University of Vienna
- Investigators
- Rashidul Haque, MBBS,PhD, Principal investigator, International Centre for Diarrhoeal Disease Research, BangladeshHarald Noedl, MD, MCTM,PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356005
- Sponsor's protocol ID
- ICDDRB #2006-024
- Other IDs
- MUW #218/2006
- Status last verified
- Oct 2012
- First submitted
- 24 Jul 2006
- Last updated
- 1 Nov 2012
- Results posted
- No
Publications
Thriemer K, Starzengruber P, Khan WA, Haque R, Marma AS, Ley B, Vossen MG, Swoboda P, Akter J, Noedl H. Azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in Bangladesh: an open-label randomized, controlled clinical trial. J Infect Dis. 2010 Aug 15;202(3):392-8. doi: 10.1086/653710.
PubMed 20557237
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh: An Open Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00356005
- Acronym / sponsor ID
- ICDDRB #2006-024
- Conditions
- Uncomplicated Falciparum Malaria
- Keywords
- falciparum malaria, therapy, azithromycin, artesunate, Coartem, Bangladesh
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Armed Forces Research Institute of Medical Sciences, Thailand
- Study start
- Aug 2006
- Primary completion
- Aug 2007 (actual)
- First posted
- 25 Jul 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 investigate the efficacy of azithromycin combination therapy with artesunate for the treatment of uncomplicated falciparum malaria in Bangladesh.
Detailed description
In view of spreading antimalarial drug resistance there is an urgent need for new combination treatments for a disease that kills more than one million people every year. Azithromycin is a macrolide antibiotic that is particularly attractive due to its safety in children and experience with use in pregnancy. Recent trials suggest that azithromycin has a strong potential as an antimalarial. The purpose of this study is to investigate the efficacy of azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in 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 plus artesunateAzithromycin + Artesunate treatment |
| Artesunate | Active comparator | Drug: ArtesunateArtesunate treatment controls |
Who may qualify
- Ages
- 8 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
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 lumefantrine or to drugs with similar chemical structures
- Malaria drug therapy administered in the past 30 days by history
- Previous participation in this trial, or participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study
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 |
|---|---|---|
| azithromycin plus artesunate | Drug | Azithromycin + Artesunate |
| Artesunate | Drug | Artesunate |
Primary outcome
Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42.
Time frame: 42 days
1 secondary outcome
Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT).
Time frame: 42
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 1 Nov 2012.
- Derived from this study: PubMed 20557237Thriemer K, Starzengruber P, Khan WA, Haque R, Marma AS, Ley B, Vossen MG, Swoboda P, Akter J, Noedl H. Azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in Bangladesh: an open-label randomized, controlled clinical trial. J Infect Dis. 2010 Aug 15;202(3):392-8. doi: 10.1086/653710.
Related trials for Uncomplicated Falciparum Malaria
RecruitingPhase 2
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2)
Uncomplicated Plasmodium Falciparum Malaria
Not yet recruitingObservational study
Ethiopian Antimalarial Therapeutic Efficacy Study 2026
Plasmodium Vivax Malaria Without Complication, Plasmodium Falciparum Malaria (Uncomplicated)
Not yet recruitingPhase 4
Study to Assess Safety and Clinical Responses With Coartem® Baby Dispersible Tablets in Paediatric Patients Weighing 2 to <5 kg With Uncomplicated Malaria
Malaria
Not yet recruitingPhase 2
A Phase 2A Study of a Novel Antimalarial Pyrrolidinamide in Adult Patients With Uncomplicated P. Falciparum Malaria
Malaria, Falciparum
RecruitingPhase 2
Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria
Malaria (Plasmodium Falciparum)
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.
Rashidul Haque, MBBS,PhD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
Harald Noedl, MD, MCTM,PhD principal investigator
Medical University of Vienna
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 azithromycin plus artesunate and Artesunate in people with Uncomplicated 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 6 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 1 Nov 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 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?
Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42. (time frame: 42 days). 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 NCT00356005, 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 1 Nov 2012.