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Parasitic Clearance and Recurrence Rates Among Patients With Vivax Malaria (BCAPES)

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ClinicalTrials.gov Identifier: NCT01784315
Recruitment Status : Unknown
Verified November 2013 by Dr.Yeshey Dorjey, Ministry of Health, Bhutan.
Recruitment status was:  Recruiting
First Posted : February 5, 2013
Last Update Posted : November 25, 2013
Sponsor:
Collaborators:
Asia Pacific Malaria Elimination Network
Menzies School of Health Research
Information provided by (Responsible Party):
Dr.Yeshey Dorjey, Ministry of Health, Bhutan

Brief 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. 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.

Condition or disease Intervention/treatment
Parasitemia Drug: Artemisinin combination therapies (ACT)will be used for Chloroquine resistant P.vivax Drug: Chloroquine and Primaquine

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 Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: PARASITIC CLEARANCE AND RECURRENCE RATES AMONG PATIENTS WITH VIVAX MALARIA ON CHLOROQUINE AND PRIMAQUINE THERAPY
Study Start Date : March 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014


Group/Cohort Intervention/treatment
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

Drug: Artemisinin combination therapies (ACT)will be used for Chloroquine resistant P.vivax
4 tablets of ACT on 0,8,24,36,48 and 60 hours will be given for Chloroquine resistant P.vivax infection.
Other Name: ACT

Drug: Chloroquine and Primaquine
Chloroquine:10mg/kg for day1,2 and 5mg/kg for day 3 Primaquine: 0.25mg/kg daily for 14 days.
Other Names:
  • Chloroquine(CQ)
  • Primaquine (PQ)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Genotyping of P.vivax strains in Bhutan. [ Time Frame: 12 months. ]
    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.


Other Outcome Measures:
  1. To measure Haemoglobin variations during the malarial infection with treatment. [ Time Frame: 12 months. ]
    Finger prick blood will be taken to check Haemoglobin levels on day 0,3, 7, 14, 28, 35, 42 and at the end of study(ie at the end of 12months).


Biospecimen Retention:   Samples With DNA
Filter blot paper will be retained to study the whole genome of P.vivax malaria in Bhutan.


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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784315


Contacts
Contact: Dr.Yeshey Dorjey 97517745239 yesheydorjey@yahoo.com
Contact: Dr.Kinley Penjor 97517619191 kalyx25@gmail.com

Locations
Bhutan
Vector Diseases Control Program, Gelephu Not yet recruiting
Gelephu, Bhutan, 00975
Contact: Dr.Yeshey Dorjey    97517745239    yesheydorjey@yahoo.com   
Contact: Dr.Kinley Penjor    97517619191    kalyx25@gmail.com   
Principal Investigator: Tobgyel Drukpa         
Sub-Investigator: Dr.Tashi Peldon         
Sub-Investigator: Dr.Kinley Penjor         
Vector Diseases Control Program, Gelephu Recruiting
Gelephu, Bhutan, 00975
Contact: Dr.Yeshey Dorjey    97517745239    yesheydorjey@yahoo.com   
Contact: Dr.Kinley Penjor    97517619191    kalyx25@gmail.com   
Sub-Investigator: Tobgay Drukpa         
Sub-Investigator: Dr.Tashi Peldon         
Sub-Investigator: Dr.Kinley Penjor         
Mr. Thinly Recruiting
Sarpang, Bhutan, 00975
Contact: Yeshey Dorjey, MBBS    008801534689426    yesheydorjey@yahoo.com   
Sub-Investigator: Dr. Kinly Penjor, MBBS         
Sponsors and Collaborators
Ministry of Health, Bhutan
Asia Pacific Malaria Elimination Network
Menzies School of Health Research
Investigators
Principal Investigator: Dr.Yeshey Dorjey Ministry of Health, Bhutan

Additional Information:
Responsible Party: Dr.Yeshey Dorjey, Principal Investigator, Ministry of Health, Bhutan
ClinicalTrials.gov Identifier: NCT01784315     History of Changes
Other Study ID Numbers: BCAPES
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Dr.Yeshey Dorjey, Ministry of Health, Bhutan:
The presence of parasites in the blood

Additional relevant MeSH terms:
Malaria
Recurrence
Malaria, Vivax
Parasitemia
Protozoan Infections
Parasitic Diseases
Disease Attributes
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Chloroquine
Chloroquine diphosphate
Primaquine
Artemisinins
Artemisinine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides