Falciparum MalariaNCT00157859
To Evaluate Current Efficacy of Antimalarials Used in Timika, Papua, Indonesia
A study testing Chloroquine and sulphadoxine-pyrimethamine in people with Falciparum Malaria and Vivax Malaria, run by Menzies School of Health Research at 1 site in Indonesia.
Trial summary
Multidrug resistant strains of P.falciparum and P.vivax are becoming increasingly prevalent in the Asia Pacific rim. To determine the efficacy of locally recommended antimalarial protocols in Papua, Indonesia, consecutive patients presenting to a rural clinic were enrolled into a prospective efficacy study. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Falciparum Malaria, Vivax Malaria
- What is being tested?
- Chloroquine and sulphadoxine-pyrimethamine
- How many people
- 150 participants
- Where
- 1 siteIndonesia
- Study dates
- Apr 2004to Sep 2004
- Phase
- Interventional
- 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 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -Male and female patients at least one 1year of age and weighing more than 10kg.
- -Microscopic confirmation of P. falciparum and /or P.vivax infection (any parasitaemia).
- -Fever (axillary temperature >37.5oC) or history of fever in the last 48 hours.
- -Able to participate in the trial and comply with the clinical trial protocol
- -Written informed consent to participate in trial; verbal consent in presence of literate witness is required for illiterate patients, and written consent from parents/guardian for children below age of consent
Who cannot join
- Pregnancy or lactation
- -Inability to tolerate oral treatment
- -Signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment
- -Known hypersensitivity or allergy to artemisinin derivatives
- -Serious underlying disease (cardiac, renal or hepatic)
- -Parasitaemia >4%
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
SP9 & SP12 Public Health- Malaria control clinics
Timika, Special Region of Papua
About this study
Official title: To Evaluate the Efficacy of Chloroquine and SP for Acute Uncomplicated P. Falciparum and the Efficacy of Chloroquine for Acute Uncomplicated P. Vivax in the Timika Region of Papua, Indonesia.
Multidrug resistant strains of P.falciparum and P.vivax are becoming increasingly prevalent in the Asia Pacific rim. To determine the efficacy of locally recommended antimalarial protocols in Papua, Indonesia, consecutive patients presenting to a rural clinic were enrolled into a prospective efficacy study. Patients with uncomplicated falciparum malaria were treated with chloroquine plus sulfadoxine-pyrimethamine and those with vivax malaria with chloroquine monotherapy. Patients failing therapy received unsupervised oral quinine +/- doxycycline for 7 days. Follow-up was continued for 42 days for falciparum malaria and 28 days for vivax malaria.
The study hypothesis was that current recommended antimalarial protocols were no longer effective.
- Conditions
- Falciparum Malaria, Vivax Malaria
- Being tested
- Chloroquine and sulphadoxine-pyrimethamine
- Keywords
- Falciparum, Vivax, Papua, Chloroquine, Sulphadoxine-pyrimethamine
- Medical subject headings
- Malaria, Falciparum, Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloroquine and sulphadoxine-pyrimethamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
• 42 day cure rate; corrected for reinfection by PCR genotyping.
• Overall Cure Rate at Day 42
Secondary outcomes (6)
• Overall day 28 cure rate for P.falciparum. This will allow comparison with previous historical data at this time point.
• Parasite reduction. Parasite reduction will be calculated at Days 1, 2 and 3 after initiation of trial treatment as percentage of parasites/uL compared to parasite density before the first dose of treatment.
• Proportion of patients with a negative slide at Days 1, 2 and 3
• Gametocyte Carriage. Anti-gametocyte activity will be measured by the proportion of patients with a peripheral gametocytaemia between day 7 to day 28.
• Early Treatment Failure (ETF)
• Late Treatment Failure (LTF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falciparum 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, National Health and Medical Research Council, Australia, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Investigators
- Emiliana Tjitre, PhD, Principal investigator, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157859
- Sponsor's protocol ID
- Timika_FP_VP
- Other IDs
- Wellcome Trust ME028458MES
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy of Chloroquine and SP for Acute Uncomplicated P. Falciparum and the Efficacy of Chloroquine for Acute Uncomplicated P. Vivax in the Timika Region of Papua, Indonesia.
- ClinicalTrials.gov ID
- NCT00157859
- Acronym / sponsor ID
- Timika_FP_VP
- Conditions
- Falciparum Malaria, Vivax Malaria
- Keywords
- Falciparum, Vivax, Papua, Chloroquine, Sulphadoxine-pyrimethamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- Wellcome Trust, National Health and Medical Research Council, Australia, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Study start
- Apr 2004
- Study completion
- Sep 2004
- First posted
- 12 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.
Multidrug resistant strains of P.falciparum and P.vivax are becoming increasingly prevalent in the Asia Pacific rim. To determine the efficacy of locally recommended antimalarial protocols in Papua, Indonesia, consecutive patients presenting to a rural clinic were enrolled into a prospective efficacy study. Patients with uncomplicated falciparum malaria were treated with chloroquine plus sulfadoxine-pyrimethamine and those with vivax malaria with chloroquine monotherapy. Patients failing therapy received unsupervised oral quinine +/- doxycycline for 7 days. Follow-up was continued for 42 days for falciparum malaria and 28 days for vivax malaria.
The study hypothesis was that current recommended antimalarial protocols were no longer effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- -Male and female patients at least one 1year of age and weighing more than 10kg.
- -Microscopic confirmation of P. falciparum and /or P.vivax infection (any parasitaemia).
- -Fever (axillary temperature >37.5oC) or history of fever in the last 48 hours.
- -Able to participate in the trial and comply with the clinical trial protocol
- -Written informed consent to participate in trial; verbal consent in presence of literate witness is required for illiterate patients, and written consent from parents/guardian for children below age of consent
Key exclusion criteria (6 listed)
- Pregnancy or lactation
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 |
|---|---|---|
| Chloroquine and sulphadoxine-pyrimethamine | Drug | – |
Primary outcome
• 42 day cure rate; corrected for reinfection by PCR genotyping.
• Overall Cure Rate at Day 42
6 secondary outcomes
• Overall day 28 cure rate for P.falciparum. This will allow comparison with previous historical data at this time point.
• Parasite reduction. Parasite reduction will be calculated at Days 1, 2 and 3 after initiation of trial treatment as percentage of parasites/uL compared to parasite density before the first dose of treatment.
• Proportion of patients with a negative slide at Days 1, 2 and 3
• Gametocyte Carriage. Anti-gametocyte activity will be measured by the proportion of patients with a peripheral gametocytaemia between day 7 to day 28.
• Early Treatment Failure (ETF)
• Late Treatment Failure (LTF)
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 12 Sep 2005.
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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.
Emiliana Tjitre, PhD principal investigator
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chloroquine and sulphadoxine-pyrimethamine in people with Falciparum Malaria and Vivax Malaria, run by Menzies School of Health Research at 1 site in Indonesia.
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 6 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 12 Sep 2005. 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 Indonesia. 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.
What does the primary outcome measure?
• 42 day cure rate; corrected for reinfection by PCR genotyping.. 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 12 Sep 2005.