- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03384472
Malaria Genetic Surveillance in Cambodia
Integrating Genetic Epidemiology as an Intensified Surveillance Tool Into the National Centre for Parasitology, Entomology and Malaria Control of Cambodia
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This is a prospective observational study of patients with clinical Plasmodium falciparum infection using parasite DNA from point-of-care fingerprick dried blood spot samples as well as a short survey on patient demographics, employment, travel, and mobile phone use to study P. falciparum parasite genotypes, population characteristics, and gene flow patterns.
On inclusion in the study and before standard treatment is administered, dried blood spots (DBS) will be obtained through fingerprick blood sampling from patients, with three blood spots on one piece of filter paper being obtained from each patient. Each blood spot will contain ~20µl of blood, for a total of ~60µl of blood being collected from each patient for the study.
In order to have a greater understanding of the possible sites of malaria transmission and to relate genetic diversity to geographic location, patients or their parents/guardians will also be asked a short set of questions on demographics, their places of residence and work, recent mobile phone use, and their history of travel in the last 2 months. As some of this information can be sensitive, during the consent process the patient will be given the option of not providing some or all of this information without needing to provide a reason. This is explained on the patient information sheet. For those who do not want to provide information, this will be documented in the survey form. A duplicate of the sample barcode will be placed on this same form, so the information therein can be matched with the relevant blood spot and its related genetic data, while retaining sample anonymity.
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Male or female >6 months of age
- P. falciparum malaria as confirmed by positive rapid diagnostic test or asexual forms of P. falciparum on blood smear microscopy (may be mixed with non-falciparum Plasmodium species)
- Written informed consent by patient, parent/guardian, or legally authorised representative to participate in the study
Exclusion Criteria:
• None
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Annual maps and reports on the prevalence of drug resistance-linked genetic mutations in P. falciparum parasites in Cambodia
Tidsramme: up to 12 months
|
up to 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Population structure of P.falciparum parasites
Tidsramme: up to 12 months
|
By using population genetics and clustering techniques, such as Principal Component Analysis and phylogeny
|
up to 12 months
|
Gene flow patterns of P. falciparum malaria parasites in Cambodia
Tidsramme: up to 12 months
|
up to 12 months
|
|
Likely geographic origin of P. falciparum malaria parasites in Cambodia
Tidsramme: up to 12 months
|
up to 12 months
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BIOINF1601
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .