- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00315809
Molecular Epidemiology of Leprosy - Philippines
22. juni 2011 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
310
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Cebu City, Filippinerne, 6014
- Leonard Wood Memorial Center
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Fremadrettet
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Varalakshmi D Vissa, PhD, Colorado State University
- Ledende efterforsker: Maria Felicio-Balagon, MD, Leonard Wood Memorial, Cebu, Phillippines
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.
Generelle publikationer
- 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.
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. april 2006
Studieafslutning (Faktiske)
1. december 2010
Datoer for studieregistrering
Først indsendt
17. april 2006
Først indsendt, der opfyldte QC-kriterier
17. april 2006
Først opslået (Skøn)
19. april 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. juni 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juni 2011
Sidst verificeret
1. juni 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 05-0080
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 .