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Study on the Treatment of Vivax Malaria (VHX)

27. august 2013 opdateret af: University of Oxford

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

This is a randomised open label trial with follow up for 1 year. 660 adults and children above 6 months diagnosed with acute Plasmodium vivax will be randomised into 3 groups, either chloroquine, artesunate, or chloroquine/primaquine therapy. Participants will be screened on the day of inclusion then followed weekly for 8 visits and every 4 weeks until week 52. The primary objective of the study is to compare the efficacy of the WHO and Thai Ministry of Public Health recommended radical curative regimen of chloroquine and primaquine with the currently used monotherapy regimens of chloroquine and artesunate along the Thai-Burmese border.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

655

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Mae Sot, Thailand
        • Shoklo Malaria Research Unit

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 måneder og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / 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.
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.
25 mg base/kg given in divided doses (10,10,5) over 3 days; Absolute range 20-30 mg/kg.
Eksperimentel: Chloroquine/Primaquine
Chloroquine 3 days and Primaquine 14 days
Chloroquine 3 days and Primaquine 14 days

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The first recurrence of Plasmodium vivax malaria
Tidsramme: Day 28
The first recurrence of Plasmodium vivax malaria within 28 days
Day 28

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Any recurrence of Plasmodium vivax parasitemia
Tidsramme: 1 year
Any recurrence of Plasmodium vivax parasitemia within the follow up period
1 year
Time to first recurrence, median time between episodes of vivax infections and total number of episodes
Tidsramme: 1 year
Time to first recurrence, median time between episodes of vivax infections and total number of episodes in the follow up period
1 year
Overall number of days of illness and haematocrit below 30%
Tidsramme: 1 year
Overall number of days of illness and haematocrit below 30% within the follow up period
1 year
Chloroquine level
Tidsramme: Day 7
Whole blood chloroquine level at day 7 and any day of recurrence of Plasmodium vivax malaria
Day 7
Adverse events
Tidsramme: 1 year
Adverse event profiles of artesunate, chloroquine and primaquine
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2010

Primær færdiggørelse (Faktiske)

1. oktober 2012

Studieafslutning (Faktiske)

1. oktober 2012

Datoer for studieregistrering

Først indsendt

23. februar 2010

Først indsendt, der opfyldte QC-kriterier

23. februar 2010

Først opslået (Skøn)

24. februar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2013

Sidst verificeret

1. august 2013

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Vivax malaria

Kliniske forsøg med Artesunate

3
Abonner