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

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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

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.


Condition or disease Intervention/treatment Phase
Trachoma Yaws Lymphatic Filariases Scabies Strongyloidiasis Drug: Albendazole on Day 1 Drug: Ivermectin on Day 1 Drug: Diethylcarbamazine on day 1 Drug: Azithromycin on Day 1 Drug: Azithromycin on Day 8 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Cluster Randomised Trial of the Safety of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : December 15, 2018
Actual Study Completion Date : January 1, 2019


Arm Intervention/treatment
Active Comparator: Separate Administration
'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 8'
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 8
Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 8
Other Name: Zithromax

Experimental: Co-Administration
'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 1'
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676140


Locations
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Papua New Guinea
Namatanai Hospital
Namatanai, Papua New Guinea
Sponsors and Collaborators
Lihir Medical Centre
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: Lucy John, MD National Department of Health of Papua New Guinea

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Responsible Party: Oriol Mitja, Principal Investigator, Lihir Medical Centre
ClinicalTrials.gov Identifier: NCT03676140     History of Changes
Other Study ID Numbers: ComboNTDs - CRT
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oriol Mitja, Lihir Medical Centre:
Neglected Tropical Diseases
Additional relevant MeSH terms:
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Trachoma
Filariasis
Elephantiasis, Filarial
Scabies
Strongyloidiasis
Elephantiasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases