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PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )

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ClinicalTrials.gov Identifier: NCT03664063
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Oriol Mitja, Lihir Medical Centre

Tracking Information
First Submitted Date  ICMJE September 3, 2018
First Posted Date  ICMJE September 10, 2018
Last Update Posted Date February 28, 2019
Actual Study Start Date  ICMJE September 1, 2018
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole [ Time Frame: 4 Days ]
Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
Drug levels [ Time Frame: 4 Days ]
Blood concentration of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole
Change History Complete list of historical versions of study NCT03664063 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Four days ]
Patients will undergo regular monitoring for the duration of the study - adverse events will be graded from 1 to 4 in line with the CTCAE v4.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )
Official Title  ICMJE A Pharmacokinetic and Pharmacodynamic Evaluation of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases
Brief Summary This is a Pharmacokinetic and Pharmacodynamic study evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Individuals will be randomised to receive Azithromycin alone, IDA or combination therapy. Clinical and biochemical monitoring for safety will be undertaken. Drug levels will be measured in each of the three arms to assess whether combination therapy significantly alters drug levels.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphatic Filariasis
  • Yaws
  • Trauma
Intervention  ICMJE
  • Drug: Azithromycin
    Treatment with Azithromycin single dose - weight based dosing max 2gm
  • Drug: Albendazole

    Single dose of Albendazole weight based dosing

    - 400mg

    Other Name: IDA
  • Drug: Ivermectin
    Ivermectin weight based dosing - max 21mg
    Other Name: IDA
  • Drug: Diethylcarbamazine
    Diethylcarbamazine weight based dosing - max 500mg
    Other Name: IDA
Study Arms  ICMJE
  • Active Comparator: Azithromycin for Yaws
    Patients will receive standard treatment for yaws alone
    Intervention: Drug: Azithromycin
  • Active Comparator: IDA for Lymphatic Filariasis
    Patients will receive standard IDA (Ivermectin & Diethylcarbamazine & Albendazole) treatment for Lymphatic Filariasis alone
    Interventions:
    • Drug: Albendazole
    • Drug: Ivermectin
    • Drug: Diethylcarbamazine
  • Experimental: Combination Therapy of Azithromycin for Yaws and IDA for LF
    Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time.
    Interventions:
    • Drug: Azithromycin
    • Drug: Albendazole
    • Drug: Ivermectin
    • Drug: Diethylcarbamazine
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2018)
42
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2019
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult aged 18-65
  • Able to give informed consent

Exclusion Criteria:

  • Known chronic illness
  • Hb <7 at baseline
  • Liver function or Creatinine * 1.5 Upper Limit of Normal
  • Urinary tract infection at baseline
  • Pregnancy (female participants only)
  • Routine medications which interact with study drugs
  • Lactose/Gluten intolerance
  • Permanent disability impeding study participation
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 NCT03664063
Other Study ID Numbers  ICMJE ComboNTDs-PK
Has Data Monitoring Committee No
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  ICMJE Not Provided
Responsible Party Oriol Mitja, Lihir Medical Centre
Study Sponsor  ICMJE Lihir Medical Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lihir Medical Centre
Verification Date February 2019

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