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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03676140 |
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Date of registration:
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16/09/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs )
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Scientific title:
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A Cluster Randomised Trial of the Safety of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases |
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Date of first enrolment:
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October 1, 2018 |
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Target sample size:
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20000 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03676140 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Papua New Guinea
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Contacts
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Name:
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Lucy John, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Department of Health of Papua New Guinea |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lymphatic Filariases
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Scabies
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Strongyloidiasis
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Trachoma
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Yaws
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Intervention(s)
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Drug: Albendazole on Day 1
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Drug: Azithromycin on Day 1
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Drug: Azithromycin on Day 8
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Drug: Diethylcarbamazine on day 1
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Drug: Ivermectin on Day 1
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Primary Outcome(s)
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Self Reported Adverse Event
[Time Frame: 7 Days]
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Secondary ID(s)
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ComboNTDs - CRT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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