A Phase 4 interventional study of Chloroquine and Chloroquine/Primaquine in Vivax Malaria, sponsored by University of Oxford. Completed at 3 sites in Afghanistan. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2019-01-15.
Sponsored by University of Oxford · Phase 4, Interventional, and Treatment
This is an open label two-arm randomized prospective study of two treatments for P. vivax malaria. Patients meeting study inclusion criteria will be enrolled and allocated either chloroquine alone or chloroquine plus primaquine (0.25mg/kg/day for 14 days). Patients will be followed-up for 1 year, with clinical and laboratory examinations at each visit. Patients with recurrent P. vivax infection will be treated with the same medication as initially randomized unless contraindicated. Recurrences in the two arms will be compared to estimate the risk of and mean duration to relapse, classify the relapse pattern as early or late relapse and to estimate the efficacy and safety of the study drugs.
Polymerase Chain Reaction (PCR) analysis will be used as far as possible help to distinguish between relapse and re-infection. Samples for chloroquine pharmacokinetic analysis will be collected on day 7 from each study subject as well as on the day of recurrence if within 8 weeks of chloroquine
Globally more than 100 countries are endemic of malaria and about 60% of world population are at risk of getting the infection while around 10% are harboring malaria parasite in their blood stream. Of the four species of plasmodium that infect humans, Plasmodium vivax is responsible for 50% of all malaria cases outside Africa, and is endemic in the Middle East, Asia and Western Pacific, with a lower prevalence in Central and South America a common cause of malaria in many tropical and subtropical regions. Conventional control methods are rather inefficient for preventing transmission of this species of malaria. This is partly due to the persistence of the infectious reservoir, which take the form of latent hypnozoites in the liver, producing recurrent relapses and opportunities for new transmission for several years after initial infection.
Primaquine (PQ) is the only available drug regimen which can eliminate the persisting liver stages (hypnozoites) of P. vivax,but its use for 14 days is ineffective to prevent relapses at 15 mg daily dose (0.25mg/kg) in Southeast Asia and in Brazil, and at a higher dose of 22.5 mg daily in the Southwest Pacific. Due to high relapse rates, a primaquine regimen of 30 mg daily (0.5 mg/kg) for 14 d is now widely recommended for glucose-6-phosphate dehydrogenase (G6PD) normal patients.
P.vivax is the predominant species in Pakistan and eastern Afghanistan. In this area G6PD deficiency is a common trait (7% in Pakistani and 14% in Afghan Pashtoon respectively). However facilities to test for G6PD deficiency are not available and hence routine administration of primaquine is not recommended in national guidelines because of the risk of severe haemolysis in those who cannot be tested.
Several national malaria programmes in Asia have adopted a truncated 5-day course of PQ for vivax malaria to reduce the risk of haemolysis to reasonable levels and to increases compliance rates. Recently this has been documented as being ineffective at reducing relapse rates amongst Afghan refugees in Pakistan while a supervised 14 day course can significantly reduce the frequency of second and third episodes of disease. This is also confirmed by a study in India. Use of the 14 day course is only recommended where the G6PD status of the individual is known, and, currently, where compliance with the full course can be assured. However supervision of patients for 14 day post presentation is seldom feasible in the majority of settings where vivax malaria predominates. Therefore the supposition that patients in a low literacy population will not comply with a 14 day course of treatment in the absence of supervision needs to be confirmed under normal operational conditions. Compliance in taking the drug cannot be monitored by direct observation or by chemical assay of residues in the blood because such interference may, in itself, affect compliance.
123 studies on the registry are indexed under Malaria, Vivax; 19 are open to participants now.
This study's enrollment of 593 is above the median of 150 across 103 interventional studies indexed under Malaria, Vivax.
Browse Malaria, Vivax studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard arm
Drug: Chloroquine
Chloroquine combined with primaquine
Drug: Chloroquine/Primaquine
Chloroquine 10 mg/kg on day 0 \& 1 and 5mg/kg on day 2
Drug pages: Chloroquine · Primaquine
Chloroquine 10 mg/kg on day 0 \& 1 and 5mg/kg on day 2 Primaquine (if given) 0.25mg/kg/day for 14 days
Secondary vivax attack
Completion of the 1-year (± 1 month) follow-up period without secondary vivax attack
Time frame: 1 year
secondary vivax attack
Completion of 6-months (± 1 month) follow-up without secondary vivax attack
Time frame: 6 months
G6PD prevalence
G6PD status of patients
Time frame: Time of enrollment
Recurrence
Time to first recurrence, median time between episodes of vivax infections and total number of episodes in the follow up period
Time frame: 1 year
Days of illness, haematocrit
Overall number of days of illness and haematocrit below 30%
Time frame: 1 year
Chloroquine levels
Whole blood chloroquine level at day 7 and any day of recurrence of Plasmodium vivax malaria
Time frame: Day 7
Adverse events
Adverse event profiles of chloroquine and primaquine
Time frame: 1 year
Ran from Aug 2009 to primary completion in Feb 2014, 54 months.
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Chloroquine · Primaquine