- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01074905
Study on the Treatment of Vivax Malaria (VHX)
A Randomised Open Label Study Comparing the Efficacy of Chloroquine/Primaquine, Chloroquine and Artesunate in the Treatment of Vivax Malaria Along the Thai-Burmese Border
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Considerably less attention has been paid to Plasmodium vivax epidemiology than Plasmodium falciparum. In areas of relatively low unstable transmission, which comprise the majority of P.vivax affected areas, vivax malaria is predominantly a disease of children (Luxemburger et al 1999). Chloroquine has long been the standard treatment for vivax malaria. Primaquine is recommended for radical cure of vivax malaria, but is difficult to administer due to dosing duration and side effects.
This study aims to characterize the epidemiologic history comparing the efficacy of 3 antimalarial regimens (chloroquine, artesunate, and chloroquine/primaquine) for plasmodium vivax in western Thailand. Chloroquine is currently the standard of treatment for Plasmodium vivax. Due to the long half-life or chloroquine, the first relapse of vivax malaria may be delayed. In contrast, artesunate has a very short half-life, thus, having no impact on first relapse. It is not known whether chloroquine reduces the overall number of relapses, or only delays the first relapse. There are many important questions about the biology of vivax malaria of relevance to treatment that remain unanswered. For example is the number of relapses per infection (i.e. per successful inoculation) predetermined or adaptive? If it is predetermined then suppression of the first relapse (as with chloroquine, mefloquine or piperaquine) will reduce the total number of relapses and this is a clear benefit. If it is adaptive then these drugs will simply delay the relapses and there is less clear benefit. These various uncertainties illustrate the importance of detailed comparative longitudinal evaluations. In order to characterize the biology of vivax malaria, it will be necessary to compare regimens with and without primaquine. Because of the challenges that face primaquine prescription (side effects, toxicity in G6PD deficient patients and duration of treatment), it is not commonly deployed along the Thai Burma border. In effect, we will be comparing usual practice (non primaquine regimens) with the recommended WHO and Thai MOPH practice (use of primaquine for 14 days). The information we will gather is crucial to the understanding of chloroquine and its effect on the vivax parasite. This will lead to future studies and invariably change the way we treat vivax malaria.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
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Mae Sot, Thailand
- Shoklo Malaria Research Unit
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adults and children > 6 months
- Weight > 7 kg for children
- Have not had primaquine since last Pv episode
- Participant (or parent/guardian if < 18 years old) is willing and able to give written informed consent
- Microscopic diagnosis of Plasmodium vivax mono-infection
- Ability (in the investigators opinion) and willingness of patient or parent/guardian to comply with all study requirements
Exclusion Criteria
- Allergy to artesunate, chloroquine or primaquine
- Severe malaria
- Patients with microscopic diagnosis of co-infection with Plasmodium falciparum
- Presence of any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study
- Inability to tolerate oral medication
- Pregnancy
- Blood transfusion in the last 3 months
- Antimalarial in last 2 months
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Artesunate
2 mg/kg/day as single daily dose given for 5 days; maximum dose range is 1.6 to 2.4 mg/kg/day or a total of 8 to 12 mg/kg.
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2 mg/kg/day as single daily dose given for 5 days; maximum dose range is 1.6 to 2.4 mg/kg/day or a total of 8 to 12 mg/kg.
|
Aktiv komparator: Chloroquine
25 mg base/kg given in divided doses (10,10,5) over 3 days; Absolute range 20-30 mg/kg.
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25 mg base/kg given in divided doses (10,10,5) over 3 days; Absolute range 20-30 mg/kg.
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Experimentell: Chloroquine/Primaquine
Chloroquine 3 days and Primaquine 14 days
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Chloroquine 3 days and Primaquine 14 days
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The first recurrence of Plasmodium vivax malaria
Tidsram: Day 28
|
The first recurrence of Plasmodium vivax malaria within 28 days
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Day 28
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Any recurrence of Plasmodium vivax parasitemia
Tidsram: 1 year
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Any recurrence of Plasmodium vivax parasitemia within the follow up period
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1 year
|
Time to first recurrence, median time between episodes of vivax infections and total number of episodes
Tidsram: 1 year
|
Time to first recurrence, median time between episodes of vivax infections and total number of episodes in the follow up period
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1 year
|
Overall number of days of illness and haematocrit below 30%
Tidsram: 1 year
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Overall number of days of illness and haematocrit below 30% within the follow up period
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1 year
|
Chloroquine level
Tidsram: Day 7
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Whole blood chloroquine level at day 7 and any day of recurrence of Plasmodium vivax malaria
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Day 7
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Adverse events
Tidsram: 1 year
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Adverse event profiles of artesunate, chloroquine and primaquine
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1 year
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Allmänna publikationer
- Chu CS, Phyo AP, Lwin KM, Win HH, San T, Aung AA, Raksapraidee R, Carrara VI, Bancone G, Watson J, Moore KA, Wiladphaingern J, Proux S, Sriprawat K, Winterberg M, Cheah PY, Chue AL, Tarning J, Imwong M, Nosten F, White NJ. Comparison of the Cumulative Efficacy and Safety of Chloroquine, Artesunate, and Chloroquine-Primaquine in Plasmodium vivax Malaria. Clin Infect Dis. 2018 Oct 30;67(10):1543-1549. doi: 10.1093/cid/ciy319.
- Pratt B, Zion D, Lwin KM, Cheah PY, Nosten F, Loff B. Closing the translation gap for justice requirements in international research. J Med Ethics. 2012 Sep;38(9):552-8. doi: 10.1136/medethics-2011-100301. Epub 2012 Mar 16.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Infektioner
- Vektorburna sjukdomar
- Parasitiska sjukdomar
- Protozoinfektioner
- Malaria
- Malaria, Vivax
- Läkemedels fysiologiska effekter
- Anti-infektionsmedel
- Agenter från det perifera nervsystemet
- Antivirala medel
- Analgetika
- Sensoriska systemagenter
- Antiinflammatoriska medel, icke-steroida
- Analgetika, icke-narkotiska
- Antiinflammatoriska medel
- Antireumatiska medel
- Antineoplastiska medel
- Antiprotozomedel
- Antiparasitära medel
- Antimalariamedel
- Amebicider
- Filaricider
- Antinematodala medel
- Anthelmintika
- Schistosomicider
- Antiplatyhelmintiska medel
- Klorokin
- Kloroquindifosfat
- Primaquine
- Artesunate
Andra studie-ID-nummer
- SMRU0908
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