Malaria FalciparumNCT00164216
Efficacy and Effectiveness of Combined Therapy for Uncomplicated Malaria Treatment in Peru
An observational study of Malaria Falciparum, run by Centers for Disease Control and Prevention at 1 site in Peru.
Trial summary
This is a study of the efficacy and effectiveness of combination therapy for malaria due to P. falciparum in the Loreto Department, Iquitos, Peru. The investigators will enroll subjects ≥ 1 year-old who have a diagnosis of uncomplicated malaria due to P. falciparum. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Malaria Falciparum
- What is being tested?
- mefloquine plus artesunate
- How many people
- 208 participants
- Where
- 1 sitePeru
- Study dates
- Mar 2005to Mar 2008
- Phase
- Observational
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > 1 year
- Axillary temperature ≥ 37.5ºC and/or history of fever in the previous 48 hours without any other evident cause
- Unmixed infection with P. falciparum of between 250 and 100,000 asexual parasites/mm3 as determined by microscopic exam of the thick or thin smear
- An informed consent obtained from the patient or his/her guardian (in case of patients ≤ 18 years old) and assent for children (8-18 years old)
- Willingness to come to the health facility for the following 28 days
Who cannot join
- Signs or symptoms of severe malaria
- Other severe chronic diseases (e.g., cardiologic, renal, or hepatic diseases; HIV/AIDS; severe malnutrition)
- History of allergy to any of the proposed treatment or its alternatives, i.e. mefloquine, artesunate, quinine, tetracycline, or clindamycin
- Pregnancy (based on urine test), since this group of patients receives other drugs for malaria treatment in accordance with Peruvian national guidelines.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Effectiveness of Combined Therapy With Mefloquine and Artesunate for Uncomplicated Malaria Treatment in the Loreto Region (Amazon Basin), Peru
This is a study of the efficacy and effectiveness of combination therapy for malaria due to P. falciparum in the Loreto Department, Iquitos, Peru. The investigators will enroll subjects ≥ 1 year-old who have a diagnosis of uncomplicated malaria due to P. falciparum. Patients will receive a treatment regimen consisting of mefloquine (25 mg/kg per day for two days) and artesunate (12 mg/kg per day for three days). Patients will be divided into two groups: one will receive drugs under direct supervision and the other will be instructed on how to take the drugs by themselves. Clinical and parasitologic response will be monitored for a follow-up period of 28 days. The findings of this study will be used to guide the Ministry of Health in evaluating its national policy for P. falciparum malaria treatment.
- Conditions
- Malaria Falciparum
- Being tested
- mefloquine plus artesunate
- Keywords
- malaria, combination therapy, mefloquine, artesunate, Peru, malaria, uncomplicated
- 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.
mefloquine plus artesunateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria FalciparumStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- National Institute of Health, Peru
- Responsible party
- Sponsor
- Investigators
- Alexandre Macedo de Oliveira, MD, MSc, Principal investigator, Centers for Disease Control and PreventionWilmer Marquiño Quezada, MD, Principal investigator, National Institute of Health, Peru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164216
- Sponsor's protocol ID
- CDC-NCID-4476
- Status last verified
- Sep 2012
- First submitted
- 9 Sep 2005
- Last updated
- 11 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Effectiveness of Combined Therapy With Mefloquine and Artesunate for Uncomplicated Malaria Treatment in the Loreto Region (Amazon Basin), Peru
- ClinicalTrials.gov ID
- NCT00164216
- Acronym / sponsor ID
- CDC-NCID-4476
- Conditions
- Malaria Falciparum
- Keywords
- malaria, combination therapy, mefloquine, artesunate, Peru, malaria, uncomplicated
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- National Institute of Health, Peru
- Study start
- Mar 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 14 Sep 2005 (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.
This is a study of the efficacy and effectiveness of combination therapy for malaria due to P. falciparum in the Loreto Department, Iquitos, Peru. The investigators will enroll subjects ≥ 1 year-old who have a diagnosis of uncomplicated malaria due to P. falciparum. Patients will receive a treatment regimen consisting of mefloquine (25 mg/kg per day for two days) and artesunate (12 mg/kg per day for three days). Patients will be divided into two groups: one will receive drugs under direct supervision and the other will be instructed on how to take the drugs by themselves. Clinical and parasitologic response will be monitored for a follow-up period of 28 days. The findings of this study will be used to guide the Ministry of Health in evaluating its national policy for P. falciparum malaria treatment.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 1 year
- Axillary temperature ≥ 37.5ºC and/or history of fever in the previous 48 hours without any other evident cause
- Unmixed infection with P. falciparum of between 250 and 100,000 asexual parasites/mm3 as determined by microscopic exam of the thick or thin smear
- An informed consent obtained from the patient or his/her guardian (in case of patients ≤ 18 years old) and assent for children (8-18 years old)
- Willingness to come to the health facility for the following 28 days
Key exclusion criteria (4 listed)
- Signs or symptoms of severe malaria
- Other severe chronic diseases (e.g., cardiologic, renal, or hepatic diseases; HIV/AIDS; severe malnutrition)
- History of allergy to any of the proposed treatment or its alternatives, i.e. mefloquine, artesunate, quinine, tetracycline, or clindamycin
- Pregnancy (based on urine test), since this group of patients receives other drugs for malaria treatment in accordance with Peruvian national guidelines.
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 |
|---|---|---|
| mefloquine plus artesunate | 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 11 Sep 2012.
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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.
Alexandre Macedo de Oliveira, MD, MSc principal investigator
Centers for Disease Control and Prevention
Wilmer Marquiño Quezada, MD principal investigator
National Institute of Health, Peru
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria Falciparum, run by Centers for Disease Control and Prevention at 1 site in Peru.
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 5 inclusion and 4 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 11 Sep 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 Peru. 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.
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 11 Sep 2012.