Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pathogenesis and Management of M. Ulcerans Disease, Buruli Ulcer (Buruli_Path)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02153034
Recruitment Status : Unknown
Verified March 2017 by Dr Richard Phillips, Kwame Nkrumah University of Science and Technology.
Recruitment status was:  Active, not recruiting
First Posted : June 2, 2014
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Richard Phillips, Kwame Nkrumah University of Science and Technology

Brief Summary:

Buruli ulcer is a neglected tropical disease caused by infection with Mycobacterium ulcerans (Mu) in rural parts of West Africa. It causes large skin ulcers mainly in children aged 5 to 15 years. Access to treatment is limited and many cases present late. There have been major advances in understanding the mechanism of disease together with improved diagnosis and management. The aim of the proposed studies is to identify markers predictive of a rapid response to antibiotic treatment and to investigate the pathogenesis of paradoxical reactions and oedematous lesions in Mu disease.

Infection with Mu results in a nodule under the skin which enlarges and breaks down to form an ulcer. This is because Mu produces a toxin that spreads outwards and damages subcutaneous tissue. In recent years it has been found that antibiotic treatment for 8 weeks with daily tablets and intramuscular injections heals ulcers. This is unpleasant and it would be better if the treatment could be shortened. Our previous studies suggest this may be possible. Therefore a wide range of tests will be investigated in order to identify markers for people in whom the infection is at an early stage with low numbers of Mu bacteria and low levels of toxin in the skin. During antibiotic treatment the rate of healing will be measured to find out which markers are the most reliable.

In some patients new areas of inflammation develop despite treatment and this is called a paradoxical reaction. The immune response to Mu will be investigated serially during antibiotic treatment to investigate the cause of paradoxical reactions.

About 15% of patients have oedematous disease, the most severe form of Buruli ulcer. We will study the amount of Mu toxin produced by the strain of Mu cultured from patients with this form of the disease.

Hypothesis

  • Buruli ulcer patients that heal rapidly/slowly or develop paradoxical reactions with treatment will have associated predictive viability or serum biomarkers.
  • Buruli ulcer patients with oedematous disease are associated with larger amounts of mycolactone and viable organisms

Condition or disease
Buruli Ulcer Mycobacterium Ulcerans Disease

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Study of the Pathogenesis and Management of M. Ulcerans Disease, Buruli Ulcer
Study Start Date : May 2013
Actual Primary Completion Date : December 15, 2016
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Buruli ulcer patients, no intervention
Buruli ulcer patients administered standard standard care by the attending physician
Healthy contacts, no intervention
Healthy volunteers who will be contacts of patients recruited or non-endemic controls. No intervention will be administered



Primary Outcome Measures :
  1. Measurement of serum/plasma proteins in diseased and healthy subjects [ Time Frame: Assessed for diseased participants at baseline, 8, 12, 16 weeks and only at baseline for healthy subjects ]

Secondary Outcome Measures :
  1. Viable M. ulcerans and bacterial load measurement in tissue of diseased subjects [ Time Frame: Assessed at baseline, 4, 8, 12, 16 only if lesions are not healed ]

Other Outcome Measures:
  1. Mycolactone measurement in tissue of diseased subjects [ Time Frame: Assessed at baseline, 4, 8, 12, 16 only if lesions are not healed ]
  2. Rate of healing and time to healing in diseased subjects [ Time Frame: The primary outcome measure will be assessed for each participant at the time of healing which will vary for participants ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with confirmed Buruli ulcer and healthy contacts of patients with Buruli ulcer
Criteria

Inclusion Criteria:

  • All patients 5 years old or more diagnosed as having Buruli ulcer.
  • Age-matched household contacts of patients that present with Buruli ulcer and healthy volunteers living in Buruli ulcer non-endemic communities

Exclusion Criteria:

  • Patients aged less than 5 years and those
  • Unwilling to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153034


Locations
Layout table for location information
Ghana
Tepa Government Hospital
Tepa, Ahafo Ano North district, Ghana
Agogo Presbyterian Hospital
Agogo, Asante Akim North District, Ghana
Nkawie Government Hospital
Nkawie, Atwima Nwabiangya district, Ghana
Sponsors and Collaborators
Kwame Nkrumah University of Science and Technology
Investigators
Layout table for investigator information
Principal Investigator: Richard O Phillips, FWACP,FGCP Kwame Nkrumah University of Science and Technology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr Richard Phillips, Dr, Kwame Nkrumah University of Science and Technology
ClinicalTrials.gov Identifier: NCT02153034     History of Changes
Other Study ID Numbers: MR/J01477X/1
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017
Keywords provided by Dr Richard Phillips, Kwame Nkrumah University of Science and Technology:
Buruli ulcer
Mycobacterium ulcerans disease
M. ulcerans disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Mycobacterium Infections
Buruli Ulcer
Ulcer
Pathologic Processes
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Skin Ulcer
Skin Diseases