Plasmodium Falciparum MalariaPhase 2NCT00299208
Azithromycin Combination Therapy for Malaria
A Phase 2 study testing Artesunate, Azithromycin and Quinine in people with Plasmodium Falciparum Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Thailand.
Trial summary
The goal of this study is to develop a safe, well tolerated, and highly efficacious azithromycin combination treatment for uncomplicated falciparum malaria. Azithromycin is a drug that has shown potential for malaria treatment. It will be combined with other malaria drugs currently approved for treatment in Thailand. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Plasmodium Falciparum Malaria
- What is being tested?
- Artesunate, Azithromycin and Quinine
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- Start not givento Jul 2005
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute symptomatic falciparum malaria infection as determined by malaria smear with a parasite density of 100 to 100,000 asexual parasites/µL with fever, defined as >37.5ºC, during the current illness, or history (within the last 48 hours) of fever.
- Age: 20-65 years old
- Male or female. All females are required to have a negative human chorionic gonadotropic (hCG) pregnancy test (urine). All females of childbearing potential (not surgically sterile, or less than two years post 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 hospitalized for 28 days for treatment and observations.
- Otherwise healthy outpatients (with no other clinically-significant illnesses as described in Exclusion Criteria, #6).
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 state of intolerance or hypersensitivity to the study drugs quinine, artesunate, or azithromycin or to drugs with similar chemical structures (quinidine, any artemisinin derivative, and macrolides such as erythromycin).
- Malaria drug therapy administered in the past 30 days by history (quinine, chloroquine, mefloquine, artemisinin derivatives, sulfadoxine/pyrimethamine, lumefantrine).
- 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.
- Clinically significant illness (intercurrent illness e.g. pneumonia, pre-existing condition e..g. malignancy or conditions that may effect absorption of study medication e.g. severe diarrhea or any signs of malnutrition as defined clinically).
Show all 17Show fewer
- Laboratory evidence or history of significant cardiovascular, liver or renal functional abnormality, which in the opinion of the investigator would place them at increased risk. Specifically, the following will serve as exclusionary laboratory values:
- Creatinine > 1.4 X ULN (>2.0 mg/dl),
- Glucose < LLN (75 mg/dl),
- AST, ALT > 3x ULN (120 U/L), or
- Prolonged QT wave on baseline electrocardiogram (QT >0.45s)
- Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
- Signs or symptoms of severe malaria.
- Anyone who received a transfusion of red blood cells within the prior 30 days.
- Unable and/or unlikely to comprehend and/or follow the protocol.
- Self-reported alcohol and/or any other drug abuse.
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Mahidol University Hospital for Tropical Diseases
Bangkok, 10270
About this study
Official title: Phase II, Open Label, Randomized Study of Azithromycin Combination Therapy for the Treatment of Acute, Uncomplicated Falciparum Malaria
The goal of this study is to develop a safe, well tolerated, and highly efficacious azithromycin combination treatment for uncomplicated falciparum malaria. Azithromycin is a drug that has shown potential for malaria treatment. It will be combined with other malaria drugs currently approved for treatment in Thailand. About 120 people, ages 20-65, will be enrolled in Thailand. Participants will have severe cases of malaria and they will be hospitalized 28 days for treatment.
Read the detailed description
The study is aimed at identifying a well tolerated, practical and highly efficacious treatment regimen of azithromycin in combination with artesunate or quinine for uncomplicated falciparum malaria for future studies, to monitor for the tolerability and safety of these combination regimens and to compare tolerability, safety and efficacy of azithromycin when given in combination with artesunate as compared to quinine. This study is also aimed at comparing tolerability, safety and efficacy of the combination of artesunate and azithromycin when given as a single daily dose (200mg As+1000mg Az) for 3 days as compared to 2 doses of 100mg As+750mg Az per day for 3 days and to compare the tolerability, safety and efficacy of the combination of quinine and azithromycin when given as 3 daily doses of quinine (10mg/kg) + Az 500mg vs. 2 daily doses of quinine (10mg/kg) + Az 750mg when given for 3 days.
- Conditions
- Plasmodium Falciparum Malaria
- Being tested
- Artesunate, Azithromycin, Quinine
- Keywords
- Malaria
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtesunateDrug
AzithromycinDrug
QuinineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- 120 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299208
- Sponsor's protocol ID
- 03-149
- Other IDs
- A0661129
- Status last verified
- Mar 2010
- First submitted
- 3 Mar 2006
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open Label, Randomized Study of Azithromycin Combination Therapy for the Treatment of Acute, Uncomplicated Falciparum Malaria
- ClinicalTrials.gov ID
- NCT00299208
- Acronym / sponsor ID
- 03-149
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 6 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 goal of this study is to develop a safe, well tolerated, and highly efficacious azithromycin combination treatment for uncomplicated falciparum malaria. Azithromycin is a drug that has shown potential for malaria treatment. It will be combined with other malaria drugs currently approved for treatment in Thailand. About 120 people, ages 20-65, will be enrolled in Thailand. Participants will have severe cases of malaria and they will be hospitalized 28 days for treatment.
Detailed description
The study is aimed at identifying a well tolerated, practical and highly efficacious treatment regimen of azithromycin in combination with artesunate or quinine for uncomplicated falciparum malaria for future studies, to monitor for the tolerability and safety of these combination regimens and to compare tolerability, safety and efficacy of azithromycin when given in combination with artesunate as compared to quinine. This study is also aimed at comparing tolerability, safety and efficacy of the combination of artesunate and azithromycin when given as a single daily dose (200mg As+1000mg Az) for 3 days as compared to 2 doses of 100mg As+750mg Az per day for 3 days and to compare the tolerability, safety and efficacy of the combination of quinine and azithromycin when given as 3 daily doses of quinine (10mg/kg) + Az 500mg vs. 2 daily doses of quinine (10mg/kg) + Az 750mg when given for 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Acute symptomatic falciparum malaria infection as determined by malaria smear with a parasite density of 100 to 100,000 asexual parasites/µL with fever, defined as >37.5ºC, during the current illness, or history (within the last 48 hours) of fever.
- Age: 20-65 years old
- Male or female. All females are required to have a negative human chorionic gonadotropic (hCG) pregnancy test (urine). All females of childbearing potential (not surgically sterile, or less than two years post 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 hospitalized for 28 days for treatment and observations.
Key exclusion criteria (17 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 state of intolerance or hypersensitivity to the study drugs quinine, artesunate, or azithromycin or to drugs with similar chemical structures (quinidine, any artemisinin derivative, and macrolides such as erythromycin).
- Malaria drug therapy administered in the past 30 days by history (quinine, chloroquine, mefloquine, artemisinin derivatives, sulfadoxine/pyrimethamine, lumefantrine).
- 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 |
|---|---|---|
| Artesunate | Drug | – |
| Azithromycin | Drug | – |
| Quinine | 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 27 Aug 2010.
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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, Azithromycin and Quinine in people with Plasmodium Falciparum Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Thailand.
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 17 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 27 Aug 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 Thailand. 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.
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 Aug 2010.