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

NCT ID: NCT03676140

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-01-01

Brief Summary

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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

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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.

Conditions

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Trachoma Yaws Lymphatic Filariases Scabies Strongyloidiasis

Keywords

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Neglected Tropical Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Separate Administration

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

Group Type ACTIVE_COMPARATOR

Albendazole on Day 1

Intervention Type DRUG

Albendazole 400 mg oral tablet Single Dose Treatment on D1

Ivermectin on Day 1

Intervention Type DRUG

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

Diethylcarbamazine on day 1

Intervention Type DRUG

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

Azithromycin on Day 8

Intervention Type DRUG

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

Co-Administration

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

Group Type EXPERIMENTAL

Albendazole on Day 1

Intervention Type DRUG

Albendazole 400 mg oral tablet Single Dose Treatment on D1

Ivermectin on Day 1

Intervention Type DRUG

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

Diethylcarbamazine on day 1

Intervention Type DRUG

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

Azithromycin on Day 1

Intervention Type DRUG

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

Interventions

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Albendazole on Day 1

Albendazole 400 mg oral tablet Single Dose Treatment on D1

Intervention Type DRUG

Ivermectin on Day 1

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

Intervention Type DRUG

Diethylcarbamazine on day 1

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

Intervention Type DRUG

Azithromycin on Day 1

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

Intervention Type DRUG

Azithromycin on Day 8

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

Intervention Type DRUG

Other Intervention Names

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Albenza Mectizan DEC-d1 Banocide Zithromax Zithromax

Eligibility 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Lihir Medical Centre

OTHER

Sponsor Role lead

Responsible Party

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Oriol Mitja

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lucy John, MD

Role: PRINCIPAL_INVESTIGATOR

National Department of Health of Papua New Guinea

Locations

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Namatanai Hospital

Namatanai, , Papua New Guinea

Site Status

Countries

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Papua New Guinea

Other Identifiers

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ComboNTDs - CRT

Identifier Type: -

Identifier Source: org_study_id