Vivax MalariaNCT01716260
Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan
An observational study of Vivax Malaria, run by Menzies School of Health Research at 1 site in Bhutan.
Trial summary
This research is intended to study the efficacy of chloroquine (CQ) and primaquine (PQ) for Plasmodium vivax (P.vivax) infection, and also to study the recurrence rate among patients with P.vivax malaria on standard doses of CQ and PQ. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Vivax Malaria
- What is being tested?
- Chloroquine and Primaquine
- How many people
- 24 participants
- Where
- 1 siteBhutan
- Study dates
- Jan 2013to Oct 2015
- 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
Study population: Patients with P.vivax infections will be recruited from 6 sentinel sites and will be recruited for the study after informed consent is received. An amendment has been approved to extend the study to 12 sites.
Who may be able to join
- >12 months of age
- infection with P.vivax parasitaemia monoinfection
- presence of axillary temperature >37.5 degrees or history of fever during the past 24 hours
- ability to swallow oral medication
- ability and willingness to comply with the study protocol for the duration of the study, including 12 months follow up
- informed consent from the patient/parent/guardian in the case of children
Who cannot join
- Presence of general danger signs in children aged under 5 years or signs of severe malaria according to the definitions of WHO
- Presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 110 mm);
- History of haemolysis or severe anaemia
- Acute anaemia <7 mg/dL
- Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
- Regular medication, which may interfere with antimalarial pharmacokinetics
- History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)
- a positive pregnancy test or lactating
Trial locations and contacts
1 site in 1 country.
Bhutan1 site
Vector Diseases Control Program
Geylegphug
About this study
Official title: Parasitic Clearance and Recurrence Rates Among Patients With Vivax Malaria on Chloroquine and Primaquine Therapy
This research is intended to study the efficacy of chloroquine (CQ) and primaquine (PQ) for Plasmodium vivax (P.vivax) infection, and also to study the recurrence rate among patients with P.vivax malaria on standard doses of CQ and PQ. For this study, PQ will be withheld for 28 days so as to study the efficacy of CQ alone.
This study will assess whether CQ is still effective against P.vivax or whether there are resistant P.vivax strains in Bhutan.
Read the detailed description
This study aims to assess the efficacy of Chloroquine alone, withholding Primaquine until day 28. Parasitic clearance and recurrence rates will be recorded. Patients whose blood stage of parasites are not cleared with the standard dose of Chloroquine, or any recurrences before day 28, will be treated with second line treatment (ACT).
The patients blood level of Chloroquine (drug concentration) at the time of a recrudescent infection will de determined to assess whether that could be due to resistance, or due to low level of Chloroquine.
Any relapses occurring after day 28 when not receiving Primaquine, or after completion of Primaquine dosage for a total of 14 days (from day 29 to 42), will be treated with repeat doses of the initial treatment. The recurrence rates will be recorded so as to develop the next phase of the study where the two different doses of Primaquine (high dose vs. low dose) will be compared.
- Conditions
- Vivax Malaria
- Being tested
- Chloroquine, Primaquine
- Medical subject headings
- Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroquineDrug
PrimaquineDrug
| Study group | Role | What they receive |
|---|---|---|
| Chloroquine and Primaquine | Chloroquine (CQ)10mg/kg for day 1, 2 and 5mg/kg for day 3 Primaquine (PQ)0.25mg/kg/day for 14 days Receives: Drug: Chloroquine; Drug: Primaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chloroquine efficacy for P.vivax infections in Bhutan.
The purpose is to study the efficacy of Chloroquine alone by recording recrudescent rates and parasitic clearance in P.vivax patients who are given a standard dose of Chloroquine treatment.
Measured: 28 days
Secondary outcomes (1)
To study the efficacy of Primaquine.
In this study, Primaquine will be administered on day 28, and any relapse will be recorded to study relapse rates over a 12 month period.
Measured: Patients with recurrence after day 28 will be recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vivax 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Bhutan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716260
- Sponsor's protocol ID
- Bhutan_APMEN_CQ PQ_2013
- Status last verified
- Apr 2015
- First submitted
- 25 Oct 2012
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parasitic Clearance and Recurrence Rates Among Patients With Vivax Malaria on Chloroquine and Primaquine Therapy
- ClinicalTrials.gov ID
- NCT01716260
- Acronym / sponsor ID
- Bhutan_APMEN_CQ PQ_2013
- Conditions
- Vivax Malaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- Ministry of Health, Bhutan
- Study start
- Jan 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Oct 2012 (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 research is intended to study the efficacy of chloroquine (CQ) and primaquine (PQ) for Plasmodium vivax (P.vivax) infection, and also to study the recurrence rate among patients with P.vivax malaria on standard doses of CQ and PQ. For this study, PQ will be withheld for 28 days so as to study the efficacy of CQ alone.
This study will assess whether CQ is still effective against P.vivax or whether there are resistant P.vivax strains in Bhutan.
Detailed description
This study aims to assess the efficacy of Chloroquine alone, withholding Primaquine until day 28. Parasitic clearance and recurrence rates will be recorded. Patients whose blood stage of parasites are not cleared with the standard dose of Chloroquine, or any recurrences before day 28, will be treated with second line treatment (ACT).
The patients blood level of Chloroquine (drug concentration) at the time of a recrudescent infection will de determined to assess whether that could be due to resistance, or due to low level of Chloroquine.
Any relapses occurring after day 28 when not receiving Primaquine, or after completion of Primaquine dosage for a total of 14 days (from day 29 to 42), will be treated with repeat doses of the initial treatment. The recurrence rates will be recorded so as to develop the next phase of the study where the two different doses of Primaquine (high dose vs. low dose) will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chloroquine and Primaquine | – | Drug: Chloroquine, Drug: PrimaquineChloroquine (CQ)10mg/kg for day 1, 2 and 5mg/kg for day 3 Primaquine (PQ)0.25mg/kg/day for 14 days |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with P.vivax infections will be recruited from 6 sentinel sites and will be recruited for the study after informed consent is received. An amendment has been approved to extend the study to 12 sites.
Key inclusion criteria (6 listed)
- >12 months of age
- infection with P.vivax parasitaemia monoinfection
- presence of axillary temperature >37.5 degrees or history of fever during the past 24 hours
- ability to swallow oral medication
- ability and willingness to comply with the study protocol for the duration of the study, including 12 months follow up
Key exclusion criteria (8 listed)
- Presence of general danger signs in children aged under 5 years or signs of severe malaria according to the definitions of WHO
- Presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 110 mm);
- History of haemolysis or severe anaemia
- Acute anaemia <7 mg/dL
- Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
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 | Drug | Chloroquine and Primaquine |
| Primaquine | Drug | Chloroquine and Primaquine |
Primary outcome
Chloroquine efficacy for P.vivax infections in Bhutan.
Time frame: 28 days
The purpose is to study the efficacy of Chloroquine alone by recording recrudescent rates and parasitic clearance in P.vivax patients who are given a standard dose of Chloroquine treatment.
1 secondary outcome
To study the efficacy of Primaquine.
Time frame: Patients with recurrence after day 28 will be recorded.
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 27 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Vivax Malaria, run by Menzies School of Health Research at 1 site in Bhutan.
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 6 inclusion and 8 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 27 May 2016. 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 Bhutan. 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?
Chloroquine efficacy for P.vivax infections in Bhutan. (time frame: 28 days). 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 27 May 2016.