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

NCT03676140 | Completed Phase 3

• 1 other identifier: ComboNTDs - CRT
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Trachoma; Yaws; Lymphatic Filariases; Scabies; Strongyloidiasis

Keywords

Neglected Tropical Diseases

Outcome Measures

Primary Outcomes (1)

• Self Reported Adverse Event

  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.

  7 Days

Study Arms (2)

Separate Administration

ACTIVE COMPARATOR

'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 8'

Drug: Albendazole on Day 1; Drug: Ivermectin on Day 1; Drug: Diethylcarbamazine on day 1; Drug: Azithromycin on Day 8

Co-Administration

EXPERIMENTAL

'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 1'

Drug: Albendazole on Day 1; Drug: Ivermectin on Day 1; Drug: Diethylcarbamazine on day 1; Drug: Azithromycin on Day 1

Interventions

Albendazole on Day 1 DRUG

Albendazole 400 mg oral tablet Single Dose Treatment on D1

Also known as: Albenza

Co-Administration; Separate Administration

Ivermectin on Day 1 DRUG

Ivermectin 200 µg/kg oral tablet Single Dose Treatment on Day 1

Also known as: Mectizan

Co-Administration; Separate Administration

Diethylcarbamazine on day 1 DRUG

Diethylcarbamazine 6 mg/kg oral tablet Single Dose Treatment on Day 1

Also known as: DEC-d1, Banocide

Co-Administration; Separate Administration

Azithromycin on Day 1 DRUG

Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 1

Also known as: Zithromax

Co-Administration

Azithromycin on Day 8 DRUG

Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 8

Also known as: Zithromax

Separate Administration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Lihir Medical Centre: lead
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Namatanai Hospital

Namatanai, Papua New Guinea

Location

MeSH Terms

Conditions

Trachoma; Yaws; Elephantiasis, Filarial; Scabies; Strongyloidiasis; Neglected Diseases

Interventions

Albendazole; Ivermectin; Diethylcarbamazine; Azithromycin

Condition Hierarchy (Ancestors)

Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Corneal Diseases; Treponemal Infections; Spirochaetales Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Rhabditida Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Polyketides; Lactones; Piperazines; Heterocyclic Compounds, 1-Ring; Erythromycin

Study Officials

• Lucy John, MD

  National Department of Health of Papua New Guinea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2018
• First Posted: September 18, 2018
• Study Start: October 1, 2018
• Primary Completion: December 15, 2018
• Study Completion: January 1, 2019
• Last Updated: February 28, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)