- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00315809
Molecular Epidemiology of Leprosy - Philippines
22. juni 2011 oppdatert av: Colorado State University
The purpose of the study is to see if new methods can be used to determine why Multidrug Therapy (MDT), used to cure leprosy patients effectively for twenty years, is not as effective against Leprosy in the Philippines.
Researchers do not know how people get infected with leprosy or what causes the disease to relapse after cure with adequate MDT.
Blood, skin scrapings, nasal swabs and biopsies, will be collected from leprosy patients to perform tests related to the detection of the disease and the germ.
The tests will be used to find out if the bacteria in the body are related to the bacteria found in other patients or contacts.
This will help the researchers to know where these bacteria come from, and to see how they spread.
Other tests will be performed to see if the bacteria can be killed by two common medicines given to leprosy patients.
Study participants will include individuals age 18 and older presenting to Leonard Wood Memorial for the diagnosis and/or relapse of leprosy.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
The overall objectives of this study are to understand the factors leading to continued incidence of leprosy in the Philippines by novel molecular methodologies using a combination of retrospective and prospective sampling approaches.
The overall objectives include: (1) strain typing of M. leprae isolates obtained from new and relapsed leprosy patients in the Philippines to identify clusters and transmission patterns when combined with conventional epidemiological criteria; (2) to determine the viability of M. leprae by mRNA detection in specimens collected from new patients; and those with signs of relapse; (3) to identify and determine the extent of mutations conferring resistance in past and circulating M. leprae isolates from leprosy patients to two Multidrug therapy (MDT) drugs; Dapsone and Rifampicin and; (4) to detect chains of transmission in endemic populations by a retrospective analyses of isolates in sample banks when combined with strain typing information from new cases and conventional epidemiological criteria.
The following are the outcome measures for each of the objectives: (1) strain typing: identification of genotypes; (2) percent of samples from patients and their contacts containing viable M. leprae (as judged by the presence of mRNA for a panel of M. leprae genes; (3) percent of samples from patients and their contacts containing mutations in M. leprae rpoB and folP 1 genes and identification of new mutations associated with relapse and; (4) identification of matching or similar genotypes in new samples obtained from patients and their household contacts with those in retrospective samples.
Clinical specimens that contain M. leprae bacilli such as skin biopsy, slit skin smears, nasal swabs and blood are required to obtain M. leprae DNA to meet the objectives of the study.
Nasal swabs will be used for assessing the role of the nasal mucosa in infection and dissemination in leprosy.
The blood is useful for monitoring the humoral responses to infection.
Skin biopsy, slit skin smears, nasal swabs and blood will be obtained from informed consenting patients.
Enrollment and sample collection procedures will take approximately 1-2 hours.
These procedures will be performed during the patient's visit to the clinic for diagnosis and therapy for leprosy.
As part of the study, a punch biopsy from a lesion is being collected to enable sufficient quantities of DNA to be extracted for strain typing, a critical objective of this study.
Patients will be required to visit the site once more after 7-10 days to assess the biopsy site.
This visit may take 30-60 minutes.
An epidemiology survey containing demographic and clinical information will be obtained from each participant.
Study participants for prospective sample collections will include volunteering and consenting individuals, 18 years old and above, reporting at Leonard Wood Memorial (LWM) CebuSkin Clinic, Leonard Wood Memorial Center for Biomedical Research, Cebu, Philippines for the diagnosis of leprosy and/or relapse of leprosy.
Studietype
Observasjonsmessig
Registrering (Faktiske)
310
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Cebu City, Filippinene, 6014
- Leonard Wood Memorial Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Blood, nasal swabs, slit skin smears and biopsies will be obtained prospectively from individuals greater than 18 years of age, representing newly diagnosed and relapse leprosy patients.
The study participants will be obtained from LWM clinic.
DNA and RNA based methodologies will be developed and applied to obtain data necessary for substantiation of a number of factors implicated in transmission of leprosy in Philippines.
Beskrivelse
Inclusion Criteria:
1. All Leprosy patients eighteen years and above who are consulting at the LWM will be invited to participate.
Exclusion Criteria:
1. Patients unwilling to participate or unable to give informed consent will be excluded from the study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Potensielle
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Varalakshmi D Vissa, PhD, Colorado State University
- Hovedetterforsker: Maria Felicio-Balagon, MD, Leonard Wood Memorial, Cebu, Phillippines
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Kimura M, Sakamuri RM, Groathouse NA, Rivoire BL, Gingrich D, Krueger-Koplin S, Cho SN, Brennan PJ, Vissa V. Rapid variable-number tandem-repeat genotyping for Mycobacterium leprae clinical specimens. J Clin Microbiol. 2009 Jun;47(6):1757-66. doi: 10.1128/JCM.02019-08. Epub 2009 Apr 22.
- Sakamuri RM, Kimura M, Li W, Kim HC, Lee H, Kiran MD, Black WC 4th, Balagon M, Gelber R, Cho SN, Brennan PJ, Vissa V. Population-based molecular epidemiology of leprosy in Cebu, Philippines. J Clin Microbiol. 2009 Sep;47(9):2844-54. doi: 10.1128/JCM.02021-08. Epub 2009 Jul 1.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2006
Studiet fullført (Faktiske)
1. desember 2010
Datoer for studieregistrering
Først innsendt
17. april 2006
Først innsendt som oppfylte QC-kriteriene
17. april 2006
Først lagt ut (Anslag)
19. april 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. juni 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juni 2011
Sist bekreftet
1. juni 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 05-0080
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. .