ParasitemiaBCAPESNCT01784315
Parasitic Clearance and Recurrence Rates Among Patients With Vivax Malaria
An observational study of Parasitemia, run by Ministry of Health, Bhutan at 3 sites in Bhutan.
Trial summary
This research is intended to study the efficacy of CQ alone for P.vivax infection and also to study the recurrence rate among patients with P.vivax on standard dose of CQ and PQ. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Parasitemia
- What is being tested?
- Artemisinin combination therapies (ACT)will be used for Chloroquine resistant P.vivax and Chloroquine and Primaquine
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 3 sitesBhutan
- Study dates
- Mar 2013to Dec 2014
- How long will I take part?
- 12 Months
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with P.vivax infections from 6 sentinel sites reported to health facility will be recruited for the study after getting the consent signed.
Who may be able to join
- age above 12months
- infection with P.vivax
- presence of axillary temperature >37.5 or history of fever during the past 24h
- ability to swallow oral medication
- ability and willingness to comply with the study protocol for the duration of the study ie 12 months follow up
- informed consent from the patient/parent/guardian in the case of children
Who cannot join
- signs and symptoms of severe or complicated malaria requiring parenteral treatment according to WHO criteria
- severe malnutrition
- febrile conditions caused by disease other than malaria or other known underlying chronic or severe diseases
- regular medication which interferes with antimalarial pharmacokinetics
- history of hypersensitivity reactions or contraindications to the medicine tested
- positive pregnancy test or breastfeeding
- unable to or unwilling to take contraceptives
Trial locations and contacts
3 sites in 1 country.
Bhutan3 sites, 3 recruiting
- Not yet recruiting
Vector Diseases Control Program, Gelephu
Geylegphug, Gelephu, 00975
Dr.Yeshey Dorjey, 97517745239, yesheydorjey@yahoo.com
Dr.Kinley Penjor, 97517619191, kalyx25@gmail.com
- Recruiting
Vector Diseases Control Program, Gelephu
Geylegphug, Gelephu, 00975
Dr.Yeshey Dorjey, 97517745239, yesheydorjey@yahoo.com
Dr.Kinley Penjor, 97517619191, kalyx25@gmail.com
- Recruiting
Mr. Thinly
Sarpang, Sarpang District, 00975
Yeshey Dorjey, MBBS, 008801534689426, yesheydorjey@yahoo.com
Dr. Kinly Penjor, MBBS
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 CQ alone for P.vivax infection and also to study the recurrence rate among patients with P.vivax on standard dose of CQ and PQ. For this study, PQ will be withheld for 28 days so as to study the efficacy of CQ alone since masking effect over one another was found when CQ is given with PQ. So the investigators are not sure whether the recurrence is due to resistance to CQ or CQ concentration in blood is below therapeutic level or it is due to PQ is in inadequate dose. From this study the investigators will get findings like may be CQ is still working for P.vivax or no longer working for P.vivax due to resistance developed by P.vivax parasites. So for P.vivax which is not responding to CQ therapy, the investigators will go for second line treatment with ACT in a similar fashion as it is given for P. falciparum infection in Bhutan. And if the investigators find CQ is still working for P.vivax infection, the next level of study will be to compare higher dose of PQ with standard dose of PQ ( as practiced now) in lieu of bringing down the relapse rates in P. vivax infection.
Read the detailed description
In recent time in Bhutan P.vivax infection is on rise compared to other types of malaria like P.falciparum which used to be the most common infections. May be this is mainly due to intensive measures taken place in controlling the diseases especially vector control measures. So that way P.falciparum has gone now. But on other hand P.vivax has peaked the infection. The main reason could be due to resistant to Chloroquine or may be Chloroquine dose is inadequate, and it could also mean it could be due to relapses from the hypnozoites stage where Primaquine dose could be inadequate. Therefore this study is developed to study the efficacy of Chloroquine alone withholding Primaquine for day 28 slightly deviating from the current treatment protocol of Bhutan. That parasitic clearance and recurrence rates will be recorded while on Chloroquine and Primaquine separately. For those patients whose blood stage of parasites doesnt get cleared with standard dose of Chloroquine or for any recurrences occurring before day 28, will be treated with second line treatment with ACT, and the blood level of Chloroquine(drug concentration) will be determined to say whether that could be due to resistance or due to low level of Chloroquine in the blood. And for any recurrences occurring after day 28 while of Primaquine or after completion of Primaquine dosage for a total of 14 days (from day 29 to day 42) those patients will be treated in a similar fashion as initial treatment with Chloroquine and Primaquine and the recurrence rates will be recorded so as to develop next level of study where two different doses of Primaquine (high dose vs low dose) will be compared to study the efficacy of Primaquine.
- Conditions
- Parasitemia
- Being tested
- Artemisinin combination therapies (ACT)will be used for Chloroquine resistant P.vivax, Chloroquine and Primaquine
- Keywords
- The presence of parasites in the blood
- Medical subject headings
- Parasitemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemisinin combination therapies (ACT)will be used for Chloroquine resistant P.vivaxDrug
Also called ACT
4 tablets of ACT on 0,8,24,36,48 and 60 hours will be given for Chloroquine resistant P.vivax infection.
Chloroquine and PrimaquineDrug
Also called Chloroquine(CQ), Primaquine (PQ)
Chloroquine:10mg/kg for day1,2 and 5mg/kg for day 3 Primaquine: 0.25mg/kg daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Chloroquine, primaquine and ACT | Standard dose of Chloroquine( 10mg/kg on day 0 and 5mg/kg on day1 and day2) and Primaquine(0.25mg/kg for 14 days).
Artemisinin combination therapies (ACT) of 4 tablets on 0,8,24,36,48 and 60 hours will be used for Chloroquine resistant P.vivax infection Receives: Drug: Artemisinin combination therapies (ACT)will be used for Chloroquine resistant P.vivax; Drug: Chloroquine and Primaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure recurrence rates among patients with vivax malarial infection put on standard dose of Chloroquine and Primaquine
Patients with P.vivax mono-infection will be recruited for the study with a follow up for a period of 12 months. These patients will be put on standard dose of Chloroquine(10mg/Kg on day 0 and 5mg/kg on day 1, and 2) and Primaquine(0.25mg/kg)and any recurrence rates will be measured.
Measured: 12 months
Secondary outcomes (1)
Genotyping of P.vivax strains in Bhutan.
One time venous blood samples will be collected from patients infected with mixed or mono-infection of P.vivax malaria. And the genotyping will be conducted to study the strains of P.vivax malaria that exist in Bhutan.
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParasitemiaStudies 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
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Bhutan
- Sponsor type
- Other government
- Collaborators
- Asia Pacific Malaria Elimination Network, Menzies School of Health Research
- Responsible party
- Principal investigator, Dr.Yeshey Dorjey, Ministry of Health, Bhutan
- Investigators
- Dr.Yeshey Dorjey, Principal investigator, Ministry of Health, Bhutan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784315
- Sponsor's protocol ID
- BCAPES
- Acronym
- BCAPES
- Status last verified
- Nov 2013
- First submitted
- 1 Sep 2012
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. 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
- NCT01784315
- Acronym / sponsor ID
- BCAPES / BCAPES
- Conditions
- Parasitemia
- Keywords
- The presence of parasites in the blood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ministry of Health, BhutanOther government
- Collaborators
- Asia Pacific Malaria Elimination Network, Menzies School of Health Research
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 5 Feb 2013 (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 CQ alone for P.vivax infection and also to study the recurrence rate among patients with P.vivax on standard dose of CQ and PQ. For this study, PQ will be withheld for 28 days so as to study the efficacy of CQ alone since masking effect over one another was found when CQ is given with PQ. So the investigators are not sure whether the recurrence is due to resistance to CQ or CQ concentration in blood is below therapeutic level or it is due to PQ is in inadequate dose. From this study the investigators will get findings like may be CQ is still working for P.vivax or no longer working for P.vivax due to resistance developed by P.vivax parasites. So for P.vivax which is not responding to CQ therapy, the investigators will go for second line treatment with ACT in a similar fashion as it is given for P. falciparum infection in Bhutan. And if the investigators find CQ is still working for P.vivax infection, the next level of study will be to compare higher dose of PQ with standard dose of PQ ( as practiced now) in lieu of bringing down the relapse rates in P. vivax infection.
Detailed description
In recent time in Bhutan P.vivax infection is on rise compared to other types of malaria like P.falciparum which used to be the most common infections. May be this is mainly due to intensive measures taken place in controlling the diseases especially vector control measures. So that way P.falciparum has gone now. But on other hand P.vivax has peaked the infection. The main reason could be due to resistant to Chloroquine or may be Chloroquine dose is inadequate, and it could also mean it could be due to relapses from the hypnozoites stage where Primaquine dose could be inadequate. Therefore this study is developed to study the efficacy of Chloroquine alone withholding Primaquine for day 28 slightly deviating from the current treatment protocol of Bhutan. That parasitic clearance and recurrence rates will be recorded while on Chloroquine and Primaquine separately. For those patients whose blood stage of parasites doesnt get cleared with standard dose of Chloroquine or for any recurrences occurring before day 28, will be treated with second line treatment with ACT, and the blood level of Chloroquine(drug concentration) will be determined to say whether that could be due to resistance or due to low level of Chloroquine in the blood. And for any recurrences occurring after day 28 while of Primaquine or after completion of Primaquine dosage for a total of 14 days (from day 29 to day 42) those patients will be treated in a similar fashion as initial treatment with Chloroquine and Primaquine and the recurrence rates will be recorded so as to develop next level of study where two different doses of Primaquine (high dose vs low dose) will be compared to study the efficacy of Primaquine.
Study design
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chloroquine, primaquine and ACT | – | Drug: Artemisinin combination therapies (ACT)will be used for Chloroquine resistant P.vivax, Drug: Chloroquine and PrimaquineStandard dose of Chloroquine( 10mg/kg on day 0 and 5mg/kg on day1 and day2) and Primaquine(0.25mg/kg for 14 days). Artemisinin combination therapies (ACT) of 4 tablets on 0,8,24,36,48 and 60 hours will be used for Chloroquine resistant P.vivax infection |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with P.vivax infections from 6 sentinel sites reported to health facility will be recruited for the study after getting the consent signed.
Key inclusion criteria (6 listed)
- age above 12months
- infection with P.vivax
- presence of axillary temperature >37.5 or history of fever during the past 24h
- ability to swallow oral medication
- ability and willingness to comply with the study protocol for the duration of the study ie 12 months follow up
Key exclusion criteria (7 listed)
- signs and symptoms of severe or complicated malaria requiring parenteral treatment according to WHO criteria
- severe malnutrition
- febrile conditions caused by disease other than malaria or other known underlying chronic or severe diseases
- regular medication which interferes with antimalarial pharmacokinetics
- history of hypersensitivity reactions or contraindications to the medicine tested
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 |
|---|---|---|
| Artemisinin combination therapies (ACT)will be used for Chloroquine resistant P.vivaxAlso: ACT4 tablets of ACT on 0,8,24,36,48 and 60 hours will be given for Chloroquine resistant P.vivax infection. | Drug | Chloroquine, primaquine and ACT |
| Chloroquine and PrimaquineAlso: Chloroquine(CQ), Primaquine (PQ)Chloroquine:10mg/kg for day1,2 and 5mg/kg for day 3 Primaquine: 0.25mg/kg daily for 14 days. | Drug | Chloroquine, primaquine and ACT |
Primary outcome
To measure recurrence rates among patients with vivax malarial infection put on standard dose of Chloroquine and Primaquine
Time frame: 12 months
Patients with P.vivax mono-infection will be recruited for the study with a follow up for a period of 12 months. These patients will be put on standard dose of Chloroquine(10mg/Kg on day 0 and 5mg/kg on day 1, and 2) and Primaquine(0.25mg/kg)and any recurrence rates will be measured.
1 secondary outcome
Genotyping of P.vivax strains in Bhutan.
Time frame: 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Related InfoLink provided by the sponsor.
Related trials for Parasitemia
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.
Dr.Yeshey Dorjey principal investigator
Ministry of Health, Bhutan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parasitemia, run by Ministry of Health, Bhutan at 3 sites 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 7 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: status not confirmed, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr.Yeshey Dorjey (97517745239, yesheydorjey@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure recurrence rates among patients with vivax malarial infection put on standard dose of Chloroquine and Primaquine (time frame: 12 months). 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 25 Nov 2013.