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Trial record 13 of 28 for:    "Conjunctival Disease" | "Azithromycin"

Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs )

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: NCT03676140
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Oriol Mitja, Lihir Medical Centre

Tracking Information
First Submitted Date  ICMJE September 16, 2018
First Posted Date  ICMJE September 18, 2018
Last Update Posted Date February 28, 2019
Actual Study Start Date  ICMJE October 1, 2018
Actual Primary Completion Date December 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2018)
Self Reported Adverse Event [ Time Frame: 7 Days ]
The incidence of self-reported adverse events following MDA. We will collect data on the presence of common symptoms/signs prior to drug administration. All patients will be reviewed 24-48 hours after treatment and asked to report adverse events. We will calculate the proportion of newly occurring adverse events following treatment and calculate the whether the proportion of patients experiencing an adverse event differs between study arms.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03676140 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
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 Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs )
Official Title  ICMJE A Cluster Randomised Trial of the Safety of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases
Brief Summary

This is a cluster randomised trial evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF.

Treatment will be provided as a single dose Mass Drug Administration (MDA) to the whole community. Communities will be randomised to receive either treatment with IDA and Azithromycin on the same day or separately.

Active monitoring for adverse events will be conducted and the frequency of adverse events compared between individuals receiving combined MDA or separate MDA.

Detailed Description

Recent studies have shown that single-dose combination therapy with three antifilarial drugs (Ivermectin [IVE] + DEC + ALB) called IDA is superior to current regimens used in LF elimination and may help accelerate LF elimination. WHO guidelines have changed to recommend IDA in countries endemic for LF outside sub-Saharan Africa like Papua New Guinea.

Additional benefits of IVE are its activity against scabies and Strongyloides. Treatment with IVE has shown to reduce the high prevalence of scabies in a village and in randomized control trials elsewhere in the Pacific. Of particular importance was the finding that IVE was highly effective against Strongyloides with a >95% reduction in prevalence sustained for nine months.

Increasingly, the desirability of linking LF programs with other public health initiatives also based on MDA is being appreciated. The existing programmatic infrastructure developed for LF campaign presents an attractive vehicle for a demonstration project of integration of MDAs against multiple Neglected Tropical Diseases (NTDs). The macrolide antibiotic azithromycin (AZI) has been demonstrated to be highly effective as MDA for yaws control and AZI is a highly effective and well-tolerated antibiotic treatment for trachoma that is able to clear ocular infection with a single oral dose and is well tolerated.

Currently LF/STH/Scabies/strongyloides and yaws/trachoma are treated separately. Integration of these existing MDA programs has the potential to be highly cost-effective as a population health intervention. Integration includes both the safe co-administration of medicines and operational planning, and it is currently advocated by WHO.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Trachoma
  • Yaws
  • Lymphatic Filariases
  • Scabies
  • Strongyloidiasis
Intervention  ICMJE
  • Drug: Albendazole on Day 1
    Albendazole 400 mg oral tablet Single Dose Treatment on D1
    Other Name: Albenza
  • Drug: Ivermectin on Day 1
    Ivermectin 200 µg/kg oral tablet Single Dose Treatment on Day 1
    Other Name: Mectizan
  • Drug: Diethylcarbamazine on day 1
    Diethylcarbamazine 6 mg/kg oral tablet Single Dose Treatment on Day 1
    Other Names:
    • DEC-d1
    • Banocide
  • Drug: Azithromycin on Day 1
    Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 1
    Other Name: Zithromax
  • Drug: Azithromycin on Day 8
    Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 8
    Other Name: Zithromax
Study Arms  ICMJE
  • Active Comparator: Separate Administration
    'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 8'
    Interventions:
    • Drug: Albendazole on Day 1
    • Drug: Ivermectin on Day 1
    • Drug: Diethylcarbamazine on day 1
    • Drug: Azithromycin on Day 8
  • Experimental: Co-Administration
    'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 1'
    Interventions:
    • Drug: Albendazole on Day 1
    • Drug: Ivermectin on Day 1
    • Drug: Diethylcarbamazine on day 1
    • Drug: Azithromycin on Day 1
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 16, 2018)
20000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2019
Actual Primary Completion Date December 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to give consent

Exclusion Criteria:

  • Unable to give consent.
  • Less than 5 years of age (not eligible for ivermectin)**
  • Pregnant women (azithromycin only, not eligible for albendazole and ivermectin)
  • Lactating women (Only administered azithromycin and albendazole, not eligible for ivermectin)**
  • History of allergies to the drugs being studied
  • Residents who cannot swallow tablets

Note that patients that are not eligible for a specific drug will receive all other treatments and will be followed up through the same procedure as the other participants drug therapy to try to track any AEs attributed to specific drug combinations

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
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 NCT03676140
Other Study ID Numbers  ICMJE ComboNTDs - CRT
Has Data Monitoring Committee Not Provided
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
Plan to Share IPD: No
Responsible Party Oriol Mitja, Lihir Medical Centre
Study Sponsor  ICMJE Lihir Medical Centre
Collaborators  ICMJE London School of Hygiene and Tropical Medicine
Investigators  ICMJE
Principal Investigator: Lucy John, MD National Department of Health of Papua New Guinea
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