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Pharmacokinetics & Pharmacodynamics of Diethylcarbamazine (DEC)+ Albendazole (ALB) + Ivermectin (IVE)

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ClinicalTrials.gov Identifier: NCT02845713
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
Christopher L. King, MD, PhD, Case Western Reserve University

Brief Summary:

The study will be an open label cohort study with 2 two-treatment groups 2). Both groups will be treated with a single oral administration of Diethylcarbamazine (DEC) 6 mg/kg + Albendazole (ALB) 400 mg + Ivermectin (IVR) 200 µg/kg (IDA). One treatment group will include men and women with W. bancrofti infections (>50 Mf/ml, N=30). The other treatment group will include men and women who are free of W. bancrofti infection based on negative blood tests for both microfilariae (Mf) and circulating filarial antigen (N=30). Active follow-up for adverse events (AE) will be for 72hrs and passive follow-up for 7 days following treatment.

Participants will be followed again at 1 year to evaluate treatment efficacy. Individuals with severe AEs (grade 3 or higher) will be transported to the Agboville District Hospital and cared for by the hospital staff. Based on treatment of over 100 Lymphatic filariasis (LF) infected individuals any AEs develop within the first 72 hours following treatment and uncommonly up to 7 days post-treatment.

All individuals will be admitted to a single health center or hospital in Côte d'Ivoire.

Subjects will be monitored for 72-hours after treatment for safety and to facilitate sampling for drug analyses and safety tests. Participants will undergo clinical monitoring every 6 hours to evaluate potential adverse effects of Ivermectin + Diethylcarbamazine + Albendazole (IDA) treatment. Participants will also be monitored for hematologic, or biochemical abnormalities during the period of observation.


Condition or disease Intervention/treatment Phase
Wuchereria Bancrofti Infection Drug: Ivermectin, Diethylcarbamazine Albendazole (IDA) Phase 1

Detailed Description:

The study will be an open label cohort study with 2 two-treatment groups. Both groups will be treated with a single oral administration of DEC 6 mg/kg + ALB 400 mg + IVR 200 µg/kg (IDA). One treatment group will include men and women with W. bancrofti infections (>50 Mf/ml, N=30). The other treatment group will include men and women who are free of W. bancrofti infection based on negative blood tests for both microfilariae and circulating filarial antigen (N=30). Active follow-up for adverse events (AE) will be for 72 hours and passive follow-up for 7 days following treatment.

Participants will be followed again at 1 year to evaluate treatment efficacy. Individuals with severe AEs (grade 3 or higher) will be transported to the Agboville District Hospital and cared for by the hospital staff. Based on treatment of over 100 LF infected individuals any AEs develop within the first 72 hours following treatment and uncommonly up to 7 days post-treatment.

All individuals will be admitted to a single health center or hospital in Côte d'Ivoire.

Subjects will be monitored for 72-hours after treatment for safety and to facilitate sampling for drug analyses and safety tests. Participants will undergo clinical monitoring every 6 hours to evaluate potential adverse effects of IDA treatment. Participants will also be monitored for hematologic, or biochemical abnormalities during the period of observation.

At enrollment all subjects will be otherwise healthy adult men and women (≥18-65 years of age). All individuals will be assessed for the presence and burden of geohelminth infections, parasitic worms of the gastrointestinal tract such as hookworm, Trichuris trichiuria and Ascaris lumbricoides. This is important because two of the drugs in the combination (ALB and IVM) are active against geohelminths. Individuals with heavy geohelminth burdens may experience adverse reactions because of rapid killing of their intestinal parasites.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Single Dose Treatment With Diethylcarbamazine, Albendazole and Ivermectin in Humans With and Without Wuchereria Bancrofti Infection in Côte d'Ivoire
Actual Study Start Date : April 17, 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 4, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Single IDA dose W. bancrofti positive
Single oral dose of Ivermectin, Diethylcarbamazine Albendazole (IDA) W. bancrofti infections positive
Drug: Ivermectin, Diethylcarbamazine Albendazole (IDA)
To evaluate the safety and tolerability of triple drug therapy (a single dose of ALB, IVM and DEC)
Other Name: IDA

Active Comparator: Single IDA dose W. bancrofti negative
Single oral dose of Ivermectin, Diethylcarbamazine Albendazole (IDA) in 40 individuals who are free of W. bancrofti infection.
Drug: Ivermectin, Diethylcarbamazine Albendazole (IDA)
To evaluate the safety and tolerability of triple drug therapy (a single dose of ALB, IVM and DEC)
Other Name: IDA




Primary Outcome Measures :
  1. Drug Levels [ Time Frame: up to 12 hours ]
    Five mil-liters of blood will be taken to test drug levels


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (aggregate) [ Time Frame: up to 1 year ]
    Following drug administration, a review of subjective symptoms will be performed.

  2. Impact of treatment on Hematuria and Proteinuria [ Time Frame: up to 7 days ]
    Urine samples will be collected to examine the the presence and amount of blood and protein in the urine.

  3. Number worm nests [ Time Frame: up to 1 year ]
    In those individuals with LF, an ultrasound examination will be performed to identify the number of adult worm nests both before treatment and after.

  4. Impact of treatment on Liver Function + [ Time Frame: up to 7 days ]
    Blood samples will be collected to examine the impact of treatment on the levels of ALT, AST in the subjects blood.

  5. Impact of treatment on Hemoglobin Levels [ Time Frame: up to 7 days ]
    Blood samples will be collected to examine the impact of treatment on the levels of Hemoglobin in the subjects blood.

  6. Impact of treatment on White Blood Cells [ Time Frame: up to 7 days ]
    Blood samples will be collected to examine the impact of treatment on the levels of white blood count in subjects blood.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willingness to provide informed consent to participation in the study

    • Male or female 18-65 years of age
    • Peripheral blood microfilaremia levels >50 microfilaria/ml (treatment group 1)
    • No evidence of filarial infection by Mf and Circulating filarial antigen (CFA) testing (treatment group 2)
    • No history of taking anti-filarial medications in past 2 years

Exclusion Criteria:

Known chronic illness, e.g. tuberculosis, diabetes, renal insufficiency

  • Anemia (Hb <7 g/dl) by HemaCue
  • Not willing or able to give informed consent for the study
  • Onchocerciasis rapid test (Ov16) and/or skin snip positive for onchocerciasis
  • Permanent disability that prevents or impedes study participation and/or comprehension Pregnancy. Women will be tested with a rapid urine test for beta human chorionic gonadotropin (β-HCG)
  • Biochemical abnormalities as indicated by liver function tests, and/or creatinine >1.5 times above upper limit of the normal range.
  • Receiving any routine medications that may interfere with test drug metabolism that cannot be stopped one week prior to onset of study
  • Evidence of urinary tract infection as indicated by an active urinary sediment (>6- 8 pus/neutrophil cells per field) or 3+ nitrate on dipstick. Individuals without a gross active sediment 1 or 2 plus nitrate or with 1 + protein will not be excluded. Similarly individuals with 1+ haemoglobin on dipstick or trace amount of blood in the will not be excluded.
  • Lactose and/or gluten intolerance.

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): NCT02845713


Locations
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Côte D'Ivoire
Agboville District Hospital
Agbobille, Côte D'Ivoire
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Washington University School of Medicine

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christopher L. King, MD, PhD, Professor of International Health, Medicine and Pathology, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT02845713     History of Changes
Other Study ID Numbers: 03-16-09
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Infection
Filariasis
Elephantiasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases
Ivermectin
Albendazole
Diethylcarbamazine
Antiparasitic Agents
Anti-Infective Agents
Anthelmintics
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Filaricides
Antinematodal Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors