Clinical MalariaPhase 2NCT00322907
Cotrifazid Safety and Efficacy Against Malaria
A Phase 2 study testing Cotrifazid vs mefloquine or quinine+SP in people with Clinical Malaria, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 1 site in Papua New Guinea.
Trial summary
The purpose of this study was to assess the safety and efficacy of Cotrifazid to treat uncomplicated resistant malaria and to compare the outcome with mefloquine or quinine+sulfadoxine/pyrimethamine (SP) Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Clinical Malaria
- What is being tested?
- Cotrifazid vs mefloquine or quinine+SP
- How many people
- 330 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- Apr 2000to Jan 2003
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All subjects > 6 months of age who presented at the centres and who were diagnosed with malaria (history of fever, OptiMAL® test positive, no other major symptom) and who had already been treated for malaria in the 28 days before, could be included in the study, if the subject or legal guardian (for children) gave informed consent and if the clinician in charge would have given the standard treatment for resistant malaria independent of the study -
Who cannot join
- A subject was not to be included if the clinician preferred to use quinine for whatever reason, if the patient had one of the symptoms or signs of complicated or severe malaria (i.e. history of recent convulsion, any neurological sign or impairment of consciousness, heavy vomiting, haemoglobinuria, respiratory distress, bleeding, circulatory collapse, shock, jaundice, haemoglobin < 5 g/dl), had contra-indications for mefloquine (history of psychiatric disorder, epilepsy), or was pregnant.
- -
Trial locations and contacts
1 site in 1 country.
Papua New Guinea1 site
Health centers
Madang and Maprik, Madang and East Sepik Province
About this study
Official title: A Randomised Safety and Efficacy Trial of Rifampicin/Cotrimoxazole/Isoniazid Versus Mefloquine or Quinine+SP Against Resistant Malaria in Papua New Guinea
The purpose of this study was to assess the safety and efficacy of Cotrifazid to treat uncomplicated resistant malaria and to compare the outcome with mefloquine or quinine+sulfadoxine/pyrimethamine (SP)
Read the detailed description
Design: Open-label, block-randomised, comparative, multicentric trial. Setting: Four primary care health facilities, two in urban and two in rural areas of Madang and East Sepik Province, Papua New Guinea.
Participants: Patients of all ages with recurrent uncomplicated malaria Intervention: Random assignment to receive either Cotrifazid, mefloquine or the standard treatment of quinine+sulfadoxine/pyrimethamine (SP).
Outcome measures: Incidence of clinical and laboratory adverse events; rate of clinical and/or parasitological failure at day 14
- Conditions
- Clinical Malaria
- Being tested
- Cotrifazid vs mefloquine or quinine+SP
- Keywords
- malaria, treatment, cotrifazid, clinical trial, efficacy
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cotrifazid vs mefloquine or quinine+SPDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical treatment failure rate on day 14.
Incidence of adverse events.
Secondary outcomes (5)
Parasitological failure rate on day 14
Fever clearance time
Parasite clearance time
Symptoms clearance time
Occurrence of complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2006 (estimated)
- Study startApr 2000
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants
Sponsor and investigators
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research, Swiss Tropical & Public Health Institute
- Investigators
- Blaise Genton, MD, PhD, Principal investigator, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322907
- Sponsor's protocol ID
- Fatol 1
- Status last verified
- Oct 1999
- First submitted
- 5 May 2006
- Last updated
- 8 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Safety and Efficacy Trial of Rifampicin/Cotrimoxazole/Isoniazid Versus Mefloquine or Quinine+SP Against Resistant Malaria in Papua New Guinea
- ClinicalTrials.gov ID
- NCT00322907
- Acronym / sponsor ID
- Fatol 1
- Conditions
- Clinical Malaria
- Keywords
- malaria, treatment, cotrifazid, clinical trial, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 330 participants
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandUniversity, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research, Swiss Tropical & Public Health Institute
- Study start
- Apr 2000
- Study completion
- Jan 2003
- First posted
- 8 May 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 was to assess the safety and efficacy of Cotrifazid to treat uncomplicated resistant malaria and to compare the outcome with mefloquine or quinine+sulfadoxine/pyrimethamine (SP)
Detailed description
Design: Open-label, block-randomised, comparative, multicentric trial. Setting: Four primary care health facilities, two in urban and two in rural areas of Madang and East Sepik Province, Papua New Guinea.
Participants: Patients of all ages with recurrent uncomplicated malaria Intervention: Random assignment to receive either Cotrifazid, mefloquine or the standard treatment of quinine+sulfadoxine/pyrimethamine (SP).
Outcome measures: Incidence of clinical and laboratory adverse events; rate of clinical and/or parasitological failure at day 14
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All subjects > 6 months of age who presented at the centres and who were diagnosed with malaria (history of fever, OptiMAL® test positive, no other major symptom) and who had already been treated for malaria in the 28 days before, could be included in the study, if the subject or legal guardian (for children) gave informed consent and if the clinician in charge would have given the standard treatment for resistant malaria independent of the study -
Key exclusion criteria (2 listed)
- A subject was not to be included if the clinician preferred to use quinine for whatever reason, if the patient had one of the symptoms or signs of complicated or severe malaria (i.e. history of recent convulsion, any neurological sign or impairment of consciousness, heavy vomiting, haemoglobinuria, respiratory distress, bleeding, circulatory collapse, shock, jaundice, haemoglobin < 5 g/dl), had contra-indications for mefloquine (history of psychiatric disorder, epilepsy), or was pregnant.
- -
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 |
|---|---|---|
| Cotrifazid vs mefloquine or quinine+SP | Drug | – |
Primary outcome
Clinical treatment failure rate on day 14.
Incidence of adverse events.
5 secondary outcomes
Parasitological failure rate on day 14
Fever clearance time
Parasite clearance time
Symptoms clearance time
Occurrence of complications
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2006.
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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.
Blaise Genton, MD, PhD principal investigator
Swiss Tropical & Public Health Institute
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 Cotrifazid vs mefloquine or quinine+SP in people with Clinical Malaria, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 1 site in Papua New Guinea.
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 1 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: stopped early, as of the sponsor's last update on 8 May 2006. 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 Papua New Guinea. 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 was stopped early. Results are not available in the source record.
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?
Clinical treatment failure rate on day 14.. 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 8 May 2006.