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Trial record 20 of 50 for:    "Elephantiasis" | "Anti-Infective Agents"

Eval 3-Drug Therapy Diethylcarbamize, Albendazole and Ivermectin That Could Accelerate LF Elimination Outside of Africa

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ClinicalTrials.gov Identifier: NCT01975441
Recruitment Status : Completed
First Posted : November 4, 2013
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher L. King, MD, PhD, University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE October 28, 2013
First Posted Date  ICMJE November 4, 2013
Last Update Posted Date October 9, 2018
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf) [ Time Frame: at 36 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01975441 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
  • Percentage of subjects with total clearance of Mf at 24 months. [ Time Frame: 24 months ]
  • Percent reduction in W. bancrofti antigen levels compared to baseline measured at 24 and 36 months [ Time Frame: 24 months and 36 months ]
  • Percent of subjects who become circulating antigen negative at 24 months and 36 months after the beginning of the study [ Time Frame: 24 months and 36 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Eval 3-Drug Therapy Diethylcarbamize, Albendazole and Ivermectin That Could Accelerate LF Elimination Outside of Africa
Official Title  ICMJE Evaluate Triple-Drug Therapy With Diethylcarbamize (DEC), Albendazole (ALB) and Ivermectin (IVM) That Could Accelerate LF Elimination Outside of Africa
Brief Summary This study will determine if a combination of 3 drugs used to treat the infection that cause lymphatic filariasis (LF) due to Wuchereria bancrofti infection are more effective in killing or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given to treat this infection. The three drugs used together are called albendazole (ALB), ivermectin (IVM) and diethylcarbamazine (DEC). The usual treatment in Papua New Guinea (PNG) for lymphatic filariasis are DEC and ALB. A combination of these 3 drugs has not been previously used to treat LF.
Detailed Description

This study will determine whether a single dose of the triple drug regimen of DEC/Iver/Alb is non-inferior to annual treatments with DEC/Alb in inducing sustained clearance of Mf in LF infected subjects (>50 Mf/ml) at 36 months post-treatment. This study also tests the hypothesis that single dose of triple drug is super in sustained clearance of microfilariae compared to single dose of DEC/ALB.

There will be 3 treatment arms as follows:

  1. The comparator (standard treatment) DEC 6 mg/kg + Alb 400 mg administered annually (at 0, 12, and 24 months).
  2. DEC 6 mg/kg + Alb 400 mg given once
  3. DEC 6 mg/kg + Alb 400 mg + Iver 200 µg/kg administered once only at the beginning of the RCT (0 month).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lymphatic Filariasis
Intervention  ICMJE
  • Drug: Diethylcarbamazine
    Diethylcarbamazine 6mg/kg
    Other Name: DEC
  • Drug: Albendazole
    Albendazole 400mg
    Other Name: ALB, Albenda
  • Drug: Ivermectin
    Ivermectin 200 mcg/kg
    Other Name: IVM, Stromectol
Study Arms  ICMJE
  • Active Comparator: standard treatment
    Diethylcarbamazine 6 mg/kg + Albendazole 400 mg administered annually (at 0, 12, and 24 months).
    Interventions:
    • Drug: Diethylcarbamazine
    • Drug: Albendazole
  • Experimental: DEC 6 mg/kg + Alb 400 mg x 1
    Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once
    Interventions:
    • Drug: Diethylcarbamazine
    • Drug: Albendazole
  • Experimental: DEC + ALB + IVM
    Diethylcarbamazine 6 mg/kg + Albendazole 400 mg + Ivermectin 200 µg/kg administered once only at the beginning of the RCT (0 month)
    Interventions:
    • Drug: Diethylcarbamazine
    • Drug: Albendazole
    • Drug: Ivermectin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2016)
182
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2013)
225
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women 18-65 years
  • >50 mf/ml in finger stick blood samples
  • Willing to give informed consent

Exclusion Criteria:

  • Prior treatment for LF within last 5 years
  • Pregnant (do pregnancy test)
  • Hemoglobin < 7 g/dl
  • permanent disability, serious medical illness that prevents or impedes study participation and/or comprehension
  • AST/ALT and creatinine > 1.5 upper limit of normal.
  • Urine dipstick with glucose ≥ 2+ and/or protein ≥ 2+
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Papua New Guinea
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01975441
Other Study ID Numbers  ICMJE CWRU 3 vs 2 LF ELIM PNG
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christopher L. King, MD, PhD, University Hospitals Cleveland Medical Center
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Siba, PhD Papua New Guinea Institution for Medical Research
PRS Account University Hospitals Cleveland Medical Center
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP