Concomitant Infections of Mansonella Perstans in Tuberculosis and Buruli Ulcer Disease Patients From Ghana

NCT02281643 | Completed Phase 2 DMC

• 1 other identifier: GZ:JA 1479/5-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the influence of doxycycline treatment against Wolbachia/M. perstans on immunity against concomitant mycobacterial infections in healthy M. perstans infected individuals. In this regard, the investigators will perform a community-based randomized controlled trial (Phase 2a) in Asante Akim North District. A cohort of 200 participants who are contacts of patients with Tuberculosis or Buruli ulcer, of both sexes with no clinical condition requiring long-term medication but connected with Mansonella perstans will be investigated for the effect of doxycycline on microfilaria, the immune response and development of mycobacterial disease.

Conditions

Mansonella Perstans Infection; Buruli Ulcer; Tuberculosis; Co-infection

Keywords

Coinfection; Buruli ulcer; Tuberculosis; Mansonella perstans

Outcome Measures

Primary Outcomes (1)

• Microfilarial assessment

  Assessment of the microfilarial load

  Change from baseline microfilarial load at 12 months

Secondary Outcomes (1)

• Demonstrate development of a T helper type 1 immunity through Immunological profile of cellular immune responses

  Change from baseline T helper type 1 cytokine levels at 24 weeks

Study Arms (2)

Early doxycycline administered

EXPERIMENTAL

Early doxycycline administered - volunteers will be treated immediately with 200mg daily doxycycline for 6 weeks

Drug: Doxycycline

Delayed doxycycline administered

ACTIVE COMPARATOR

Delayed doxycycline administered-volunteers will be treated six months after the early group has received treatment with 200mg daily doxycycline for 6 weeks

Drug: Doxycycline

Interventions

Doxycycline DRUG

200mg oral doxycycline will be administered immediately (early) in the experimental arm or delayed in the comparator arm

Also known as: Vibramycim, Oracea

Delayed doxycycline administered; Early doxycycline administered

Eligibility Criteria

• Age: 9 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• M. perstans mg-positive status Good general health without any clinical condition requiring long-term medication.
• Normal renal and hepatic laboratory profiles

You may not qualify if:

• Known intolerance to the doxycycline Body weight \<40 kg Pregnancy or breastfeeding History of severe allergic reaction or anaphylaxis Alcohol or drug abuse

Sponsors & Collaborators

• Kwame Nkrumah University of Science and Technology: lead
• University of Bonn: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator

Study Sites (1)

Agogo Presbyterian Hospital

Agogo, Asante Akim North District, Ghana

Location

Related Publications (1)

• Debrah LB, Nausch N, Opoku VS, Owusu W, Mubarik Y, Berko DA, Wanji S, Layland LE, Hoerauf A, Jacobsen M, Debrah AY, Phillips RO. Epidemiology of Mansonella perstans in the middle belt of Ghana. Parasit Vectors. 2017 Jan 7;10(1):15. doi: 10.1186/s13071-016-1960-0.

  PMID: 28061905 DERIVED

MeSH Terms

Conditions

Mansonelliasis; Buruli Ulcer; Tuberculosis; Coinfection; Dipetalonema Infections

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Richard Phillips O Phillips, MBChB, PhD

  Kwame Nkrumah University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Ellis Owusu Dabo, MBChB, PhD

  Kumasi Centre for Collaborative Research

  STUDY DIRECTOR

• Alexander Y Debrah, PhD

  Kwame Nkrumah University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 26, 2014
• First Posted: November 3, 2014
• Study Start: October 1, 2014
• Primary Completion: March 15, 2017
• Study Completion: March 15, 2017
• Last Updated: March 23, 2017

Record last verified: 2017-03

Locations

GH (1)