An observational study in Leprosy, sponsored by Colorado State University. Completed at 2 sites in Colombia. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-07.
Sponsored by Colorado State University · Observational
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:
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 and/or 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 and/or 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.
52 studies on the registry are indexed under Leprosy; 13 are open to participants now.
Browse Leprosy studies →Colorado State University is the lead sponsor of 117 studies on the registry; 19 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Study participants for prospective sample collections will include volunteering and consenting individuals older than 18 years of age, representing three study groups
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Exclusion criteria for objective A.5 are one or more of the following conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All leprosy patients
Household contacts with known contact with leprosy patients
Healthy persons with no known contact with leprosy patients
Strain typing: identification of genotypes
Time frame: Dec, 2010
The record gives a start of Apr 2006, a primary completion of Apr 2013 and a completion of Apr 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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