Malaria,FalciparumPhase 3NCT00378625
Efficacy, Effect on Gametocytes and Tolerability of the Addition of Artesunate to Amodiaquine in Colombia
A Phase 3 study testing Artesunate in people with Malaria,Falciparum and Malaria, run by Centro Internacional de Entrenamiento e Investigaciones Médicas at 1 site in Colombia.
Trial summary
The primary goal of this study is to quantify the benefit of adding artesunate to amodiaquine in treating patients with uncomplicated P. falciparum malaria, in a low transmission area in Colombia. Read more about this study
- Who is it for?
- Ages 1 year to 65 years
- Conditions the study is for
- Malaria,Falciparum, Malaria, Antimalarials
- What is being tested?
- Artesunate
- How many people
- 360 participants
- Where
- 1 siteColombia
- Study dates
- Apr 2000to Mar 2006
- 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 1 year to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pure P. falciparum infection
- parasitaemia >500 and <50,000 asexual parasites/μL (subsequently the lower limit was modified to >250 asexual parasites/μL)
- age between 1 and 65 years old
- availability to return for follow-up
Who cannot join
- Pregnancy
- history of allergy to the study drugs
- history of taken complete treatment with an antimalarial drug in the previous 72 hours or sulphas, clindamycin or tetracycline in the previous week
- have a medical history of untreated hypertension or chronic heart, kidney or liver disease
- present any danger signs of severe malaria.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Ismael Roldan and Centro de Salud San Vicente
Quibdó, Departamento del Chocó, 00
About this study
Official title: Randomised, Double Blind Clinical Trial of the Efficacy, Effect on Gametocytes and Tolerability of Amodiaquine Vs Amodiaquine Plus Artesunate in the Treatment of Uncomplicated P. Falciparum Malaria in Quibdo, Colombia
The primary goal of this study is to quantify the benefit of adding artesunate to amodiaquine in treating patients with uncomplicated P. falciparum malaria, in a low transmission area in Colombia. The benefit will be assessed in terms of:
- Efficacy
- Tolerability
- Time of fever clearance
- Time of parasite clearance
- Proportion of gametocyte carriers
- Conditions
- Malaria,Falciparum, Malaria, Antimalarials
- Being tested
- Artesunate
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment failures
adverse events
gametocyte carriage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2006 (estimated)
- Study startApr 2000
- Study completionMar 2006
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
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 360 participants
Sponsor and investigators
- Lead sponsor
- Centro Internacional de Entrenamiento e Investigaciones Médicas
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Investigators
- Lyda Osorio, MD PhD, Principal investigator, Centro Internacional de Entrenamiento e Investigaciones Médicas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378625
- Sponsor's protocol ID
- A00096/990954
- Other IDs
- 2229-04-10380
- Status last verified
- Sep 2006
- First submitted
- 18 Sep 2006
- Last updated
- 20 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double Blind Clinical Trial of the Efficacy, Effect on Gametocytes and Tolerability of Amodiaquine Vs Amodiaquine Plus Artesunate in the Treatment of Uncomplicated P. Falciparum Malaria in Quibdo, Colombia
- ClinicalTrials.gov ID
- NCT00378625
- Acronym / sponsor ID
- A00096/990954
- Conditions
- Malaria,Falciparum, Malaria, Antimalarials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- Centro Internacional de Entrenamiento e Investigaciones MédicasUniversity, hospital or other
- Collaborators
- World Health Organization, Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Study start
- Apr 2000
- Study completion
- Mar 2006
- First posted
- 20 Sep 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 primary goal of this study is to quantify the benefit of adding artesunate to amodiaquine in treating patients with uncomplicated P. falciparum malaria, in a low transmission area in Colombia. The benefit will be assessed in terms of:
- Efficacy
- Tolerability
- Time of fever clearance
- Time of parasite clearance
- Proportion of gametocyte carriers
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- pure P. falciparum infection
- parasitaemia >500 and <50,000 asexual parasites/μL (subsequently the lower limit was modified to >250 asexual parasites/μL)
- age between 1 and 65 years old
- availability to return for follow-up
Key exclusion criteria (5 listed)
- Pregnancy
- history of allergy to the study drugs
- history of taken complete treatment with an antimalarial drug in the previous 72 hours or sulphas, clindamycin or tetracycline in the previous week
- have a medical history of untreated hypertension or chronic heart, kidney or liver disease
- present any danger signs of severe malaria.
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 | – |
Primary outcome
treatment failures
adverse events
gametocyte carriage
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 20 Sep 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.
Lyda Osorio, MD PhD principal investigator
Centro Internacional de Entrenamiento e Investigaciones Médicas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Artesunate in people with Malaria,Falciparum and Malaria, run by Centro Internacional de Entrenamiento e Investigaciones Médicas at 1 site in Colombia.
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 4 inclusion and 5 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 20 Sep 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 Colombia. 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?
treatment failures. The study lists 3 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 20 Sep 2006.