Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138437
Status:
COMPLETED
Last Update Posted:
2014-11-07
First Post:
2005-08-26
Brief Title:
Molecular and Immunological Tools for Detection of Strain Diversity Drug Resistance and Immunological Responses
Sponsor:
Colorado State University
Organization:
Colorado State University
Study Overview
Official Title:
Molecular Epidemiology of Leprosy in Colombia
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine what factors contribute to the continued incidence of leprosy in Colombia Study participants will include volunteering and consenting individuals older than 4 years of age representing three study groups
1 healthy persons with no known contact with leprosy patients
2 patients reporting at Instituto Colombiano de Medicina Tropical-CES and Impresa Social del Estado Sanatorio Agua de Dios with a new diagnosis of leprosy or relapse of leprosy
3 household contacts of leprosy patients described in group 2 Blood nasal swabs slit skin smears and biopsies will be taken from the volunteers to learn the strains of leprosy-causing bacteria in the area the immune responses bodys response to disease in local residents against the bacteria and the pattern of leprosy transmission Individuals will participate in this study for 1-10 days and the study will last for 3 years
1 healthy persons with no known contact with leprosy patients
2 patients reporting at Instituto Colombiano de Medicina Tropical-CES and Impresa Social del Estado Sanatorio Agua de Dios with a new diagnosis of leprosy or relapse of leprosy
3 household contacts of leprosy patients described in group 2 Blood nasal swabs slit skin smears and biopsies will be taken from the volunteers to learn the strains of leprosy-causing bacteria in the area the immune responses bodys response to disease in local residents against the bacteria and the pattern of leprosy transmission Individuals will participate in this study for 1-10 days and the study will last for 3 years
Detailed Description:
The overall objectives of this study are to understand the factors leading to continued incidence of leprosy in Colombia by novel molecular methodologies using a combination of retrospective and prospective sampling approaches using three study groups Specific objectives are 1 strain typing of M leprae isolates obtained from newly diagnosed leprosy patients and household contacts HHCs in Colombia 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 leprosy patients and HHCs 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 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 and 5 to detect compare and delineate immune response profiles to M leprae antigens as biomarkers for early detection of leprosy and prediction of clinical outcome susceptible infected and resistant individuals among three study groups Study participants for prospective sample collections will include volunteering and consenting individuals older than 4 years of age representing three study groups 1 healthy persons with no known contacts with leprosy patients 2 patients reporting at Instituto Colombiano de Medicina Tropical-CES ICMT-CES and Impresa Social del Estado Sanatorio Agua de Dios for the diagnosis of leprosy andor relapse of leprosy and 3 household contacts HHC of leprosy patients reporting at Instituto Colombiano de Medicina Tropical-CES ICMT-CES and Impresa Social del Estado Sanatorio Agua de Dios Blood nasal swabs slit skin smears and biopsies will be obtained prospectively from individuals greater than 4 years of age representing three study groups newly diagnosed and relapse leprosy patients their household contacts and healthy persons with no known contacts with leprosy patients Retrospective archived samples from past and present leprosy patients will be included when available 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 Colombia Nucleic acid based molecular methods like Multiple Locus Variable number of tandem repeat Analysis MLVA and Single Nucleotide Polymorphisms SNPs will be performed for strain typing M leprae in combination with epidemiological information to delineate the distribution of types of the organism in various regions of Colombia Other DNA markers such as mutations causing drug resistance will also be collected from the M leprae containing specimens Due to the lack of methods to cultivate M leprae viability of the organism in newly collected biological samples will be tested by mRNA detection A database will be generated which will include M leprae genotypes patient history clinical and demographic for comprehensive epidemiological analyses to monitor prevailing M leprae population structures reflective of short and long range dissemination and correlations between disease type and genotype to track evolutionary and transmission patterns Profiling of host immunological responses during infection with M leprae will be done by detection of a panel of cytokines at the level of mRNA andor protein and detection of antibodies against M leprae antigens in leprosy patients their household contacts and healthy individuals with no known history or contacts with leprosy patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None