MalariaPhase 3NCT00367653
Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.
A Phase 3 study testing Azithromycin plus Chloroquine and Mefloquine in people with Malaria, run by Pfizer at 8 sites in 6 countries.
Trial summary
To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malaria
- What is being tested?
- Azithromycin plus Chloroquine and Mefloquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 8 sitesin 6 countries
- Study dates
- Nov 2006to Sep 2007
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females and males 18 years of age and older with uncomplicated, symptomatic malaria as as indicated by the presence of both of the following:
- Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites
- Documented fever (38.5 C/101.3 F rectal or tympanic; 37.5 C/99.5 F axillary or 38 C/100.4 F oral) or history of fever (as reported by subject) within the prior 24 hours.
Who cannot join
- Severe or complicated malaria.
- Pregnant or breast-feeding women.
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Burkina Faso2 sites
Pfizer Investigational Site
Nouna
Pfizer Investigational Site
Ouagadougou, West Africa, 01
Mali2 sites
Pfizer Investigational Site
Bamako, West Africa
Pfizer Investigational Site
Bamako
About this study
Official title: A Phase 3, Randomized, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Mefloquine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Africa
To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.
- Conditions
- Malaria
- Being tested
- Azithromycin plus Chloroquine, Mefloquine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin plus ChloroquineDrug
Also called Zithromax
Azithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2)
MefloquineDrug
Mefloquine 1250 mg PO given as a split dose (750 mg [three 250 mg capsules]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Azithromycin plus Chloroquine |
| 2 | Experimental | Not described Receives: Drug: Mefloquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is noninferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in Africa.
Measured: duration of trial
The primary endpoint of the study will be the asexual P. falciparum Parasite Clearance Rates (adjusted for molecular testing determining recrudescence, true failures, from reinfection, true cures) at Day 28 in the Parasitologic Per Protocol population.
Measured: duration of trial
Secondary outcomes (2)
A secondary objective is to assess the efficacy of azithromycin plus chloroquine.
Measured: duration of trial
Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens.
Measured: duration of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2007
- Study completionSep 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 MalariaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367653
- Sponsor's protocol ID
- A0661155
- Status last verified
- Sep 2008
- First submitted
- 21 Aug 2006
- Last updated
- 16 Sep 2008
- Results posted
- No
Publications
Sagara I, Oduro AR, Mulenga M, Dieng Y, Ogutu B, Tiono AB, Mugyenyi P, Sie A, Wasunna M, Kain KC, Djimde AA, Sarkar S, Chandra R, Robbins J, Dunne MW. Efficacy and safety of a combination of azithromycin and chloroquine for the treatment of uncomplicated Plasmodium falciparum malaria in two multi-country randomised clinical trials in African adults. Malar J. 2014 Nov 25;13:458. doi: 10.1186/1475-2875-13-458.
PubMed 25425434
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Mefloquine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Africa
- ClinicalTrials.gov ID
- NCT00367653
- Acronym / sponsor ID
- A0661155
- Conditions
- Malaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 23 Aug 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.
To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Azithromycin plus Chloroquine |
| 2 | Experimental | Drug: Mefloquine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females and males 18 years of age and older with uncomplicated, symptomatic malaria as as indicated by the presence of both of the following:
- Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites
- Documented fever (38.5 C/101.3 F rectal or tympanic; 37.5 C/99.5 F axillary or 38 C/100.4 F oral) or history of fever (as reported by subject) within the prior 24 hours.
Key exclusion criteria (2 listed)
- Severe or complicated malaria.
- Pregnant or breast-feeding women.
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 ChloroquineAlso: ZithromaxAzithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2) | Drug | 1 |
| MefloquineMefloquine 1250 mg PO given as a split dose (750 mg [three 250 mg capsules]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0 | Drug | 2 |
Primary outcome
The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is noninferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in Africa.
Time frame: duration of trial
The primary endpoint of the study will be the asexual P. falciparum Parasite Clearance Rates (adjusted for molecular testing determining recrudescence, true failures, from reinfection, true cures) at Day 28 in the Parasitologic Per Protocol population.
Time frame: duration of trial
2 secondary outcomes
A secondary objective is to assess the efficacy of azithromycin plus chloroquine.
Time frame: duration of trial
Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens.
Time frame: duration of trial
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 16 Sep 2008.
- Derived from this study: PubMed 25425434Sagara I, Oduro AR, Mulenga M, Dieng Y, Ogutu B, Tiono AB, Mugyenyi P, Sie A, Wasunna M, Kain KC, Djimde AA, Sarkar S, Chandra R, Robbins J, Dunne MW. Efficacy and safety of a combination of azithromycin and chloroquine for the treatment of uncomplicated Plasmodium falciparum malaria in two multi-country randomised clinical trials in African adults. Malar J. 2014 Nov 25;13:458. doi: 10.1186/1475-2875-13-458.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin plus Chloroquine and Mefloquine in people with Malaria, run by Pfizer at 8 sites in 6 countries.
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 2 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 16 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Burkina Faso, Mali, Ghana, Kenya, Senegal and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is noninferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in Africa. (time frame: duration of trial). 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?
On the ClinicalTrials.gov record for NCT00367653, 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 16 Sep 2008.