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Complex Cutaneous Leishmaniasis Healing Study in Algeria (LeiClean)

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ClinicalTrials.gov Identifier: NCT03292835
Recruitment Status : Suspended (Political Issues in Algeria and now Covod-19 lock-down)
First Posted : September 26, 2017
Last Update Posted : September 25, 2020
Sponsor:
Collaborators:
Institut Pasteur
University of Erlangen-Nürnberg Medical School
Information provided by (Responsible Party):
K. W. Stahl, Waisenmedizin e. V. Promoting Access to Essential Medicine

Tracking Information
First Submitted Date September 18, 2017
First Posted Date September 26, 2017
Last Update Posted Date September 25, 2020
Estimated Study Start Date September 1, 2021
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 20, 2017)
Lesion Epithelisation [ Time Frame: 2 months ]
Digital photo documentation
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 20, 2017)
No healing progress with LeiClean [ Time Frame: 2 months ]
Patients who have to be hospitalised for systemic Sb(V) treatment
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Complex Cutaneous Leishmaniasis Healing Study in Algeria
Official Title Multicentric Non-Interventional Trial Evaluating Painless Hand Hygiene and LeiProtect® Dressing to Treat Complex Cutaneous Leishmaniasis in Algeria - LeiClean
Brief Summary This study evaluates the effect of clean wound management and dressing on complex zoonotic cutaneous leishmaniasis caused by L. major in the MENA region (Algeria). The patients will participate in the wound dressing themselves. The objective is to determine the amount of patients that can avoid systemic chemotherapy with pentavalent antimony which is compulsory for patients with complex CL lesions. In Algeria, this requires expensive hospital care because of the eventual toxic side effects of Sb(V).
Detailed Description

The investigator initiated, non-interventional LeiClean Trial with 100 CL patients presenting complex CL lesions, normally in need of a systemic an in-door treatment with meglumine antimoniate and in risk of systemic antimony toxicity (see inclusion criteria!) during the CL season of 2017/18 is part of the renewed cooperation treaty between the IPA and WM e. V. and originates from encouraging compassionate use observations after topical LeiClean treatment authorized by the Algerian Ministry of Health in December 2015. The study will be carried out in the ZCL region of M'Sila and Bou Saada.

The German Regulation Authority, BfArM, has granted a special approval according to §11 MPG (German regulation for Medical Devices) to the new filmogenic gel dressing LeiProtect®. The patients with complex cutaneous leishmaniasis (Giemsa and PCR confirmed) elected for indoor treatment with systemic antimony treatment are given the option for a LeiClean treatment of their lesions; they are instructed on hand hygiene and LeiProtect® dressing of their lesions which they carry out themselves at home during seven days. On day eight they come for lesion cleansing and photographic monitoring before they start another weekly LeiClean cycle. The patients can at any time opt for a conventional systemic chemotherapeutic treatment in a hospital if they are not satisfied with their healing progress. However, if the doctor realizes that after two months the hygienic wound management results in inadequate healing, he can also order hospital for the patients. The doctor will allow the patients to visualise their healing progress over the course of the trial through digital images on the computer.

After complete epithelisation of the lesions, the patients come for controls at monthly intervals up to a period of five months to check for eventual lesion relapses. The costs of the LeiClean outdoor treatment will be evaluated and compared to the already known hospital costs per patient for a three-week systemic indoor Sb(V) treatment.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Retention:   Samples With DNA
Description:

Polymerase Chain Reaction (PCR). The differentiation of parasite species in between responders and eventual non-responders using sequencing technologies established in the Institute of Clinical Microbiology, Immunology and Hygiene, FAU Erlangen and University Hospital Erlangen.

Smears with Giemsa staining.

Sampling Method Non-Probability Sample
Study Population ZCL patients in the CL endemic region of M'Sila and Bou Saada, Algeria
Condition Cutaneous Leishmaniases
Intervention Device: LeiProtect®
Filmogenic dressing gel
Other Name: Alcohol Based Hand-Rub (ABHR)
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: September 20, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2023
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subject has Giemsa and PCR proven L.major cutaneous leishmaniasis
  • Subject has complex zoonotic cutaneous leishmaniasis or Sb(V) incompatibility
  • Subject gives voluntary consent

Exclusion Criteria:

  • Immune deficiencies, skin tumours, allergy to 1,2-propylene glycol (rare)
Sex/Gender
Sexes Eligible for Study: All
Ages up to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries Algeria
 
Administrative Information
NCT Number NCT03292835
Other Study ID Numbers ALG 17/003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party K. W. Stahl, Waisenmedizin e. V. Promoting Access to Essential Medicine
Study Sponsor K. W. Stahl
Collaborators
  • Institut Pasteur
  • University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Zoubir Harrat, Dr. Pasteur Institute
PRS Account Waisenmedizin e. V. Promoting Access to Essential Medicine
Verification Date September 2020