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Trial record 58 of 102 for:    IVERMECTIN

Efficacy, Safety, and PK of Ascending Dosages of Moxidectin Versus Ivermectin Against Strongyloidiasis Stercoralis (StrongMoxy)

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ClinicalTrials.gov Identifier: NCT04056325
Recruitment Status : Not yet recruiting
First Posted : August 14, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
National Institute of Public Health, Vientiane, Laos
National Centre for Parasitology, Entomology and Malaria Control, Cambodia
Information provided by (Responsible Party):
Jennifer Keiser, Swiss Tropical & Public Health Institute

Brief Summary:
This study is a phase 2, blinded and randomized clinical trial. The phase 2a trial is single blinded and conducted in Lao, while the phase 2b trial is double-blinded and conducted in Lao and Cambodia. The study aims at providing evidence on effective doses and safety of moxidectin in adults against infection with S. stercoralis in Laos (trial 2a) and efficacy and safety of moxidectin compared to ivermectin in adults against infection with S. stercoralis in Laos and Cambodia (trial 2b). The efficacy of the treatment will be assessed by collecting three stool samples once pre-treatment and once 21 days post-treatment. The stool samples will be analyzed by a quantitative Baermann assay.

Condition or disease Intervention/treatment Phase
Strongyloides Stercoralis Infection Drug: Moxidectin Drug: Ivermectin Drug: Placebo oral tablet Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 2a: Parallel study with 7 treatment arms (including a placebo arm) Phase 2b: Parallel study with 3 treatment arms (including a placebo arm)
Masking: Single (Participant)
Masking Description: Phase 2a: single-blinded (participant and lab technician) Phase 2b: double-blinded (participant, Care Provider) PK sub-studies are single-blinded (participant)
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Pharmacokinetics of Ascending Dosages of Moxidectin Alone and in Comparison to Ivermectin Against Strongyloidiasis Stercoralis in Adults: a Randomized Controlled Trial
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 2a - Arm A
2 mg Moxidectin at day 0 administered orally
Drug: Moxidectin
Monotherapy, oral administration, single dose, fixed dose

Experimental: Phase 2a - Arm B
4 mg Moxidectin at day 0 administered orally
Drug: Moxidectin
Monotherapy, oral administration, single dose, fixed dose

Experimental: Phase 2a - Arm C
6 mg Moxidectin at day 0 administered orally
Drug: Moxidectin
Monotherapy, oral administration, single dose, fixed dose

Experimental: Phase 2a - Arm D
8 mg Moxidectin at day 0 administered orally
Drug: Moxidectin
Monotherapy, oral administration, single dose, fixed dose

Experimental: Phase 2a - Arm E
10 mg Moxidectin at day 0 administered orally
Drug: Moxidectin
Monotherapy, oral administration, single dose, fixed dose

Experimental: Phase 2a - Arm F
12 mg Moxidectin at day 0 administered orally
Drug: Moxidectin
Monotherapy, oral administration, single dose, fixed dose

Placebo Comparator: Phase 2a - Arm G
matching Placebo tablet(s) at day 0 administered orally
Drug: Placebo oral tablet
Monotherapy, oral administration, single dose, matching number of tablets

Experimental: Phase 2b - Arm A
the recommended dose moxidectin (i.e. the most promising dosage identified in trial A; between 2-12 mg) at day 0 administered orally
Drug: Moxidectin
Monotherapy, oral administration, single dose, fixed dose

Active Comparator: Phase 2b - Arm B
200 µg/kg ivermectin at day 0 administered orally
Drug: Ivermectin
Monotherapy, oral administration, single dose, weight dependent

Placebo Comparator: Phase 2b - Arm P
matching Placebo tablet(s) at day 0 administered orally
Drug: Placebo oral tablet
Monotherapy, oral administration, single dose, matching number of tablets




Primary Outcome Measures :
  1. Cure rate against Strongyloidiasis stercoralis [ Time Frame: 14-21 days after treatment ]
    The conversion from being larvae positive pre-treatment to larvae negative post-treatment, or cure rate (CR).


Secondary Outcome Measures :
  1. Larvae-reduction rate (LRR) against Strongyloidiasis stercoralis [ Time Frame: 14-21 days after treatment ]
    Larvae per gram (LPG) stool sample will be assessed by calculating the mean of the larvae counts from the three duplicate Baermann assays and divided by the mean weighted amount of these stool samples. The LRR will be calculated following: (LRR = (1-(mean at follow-up/mean at baseline))*100)

  2. CRs and LRRs against concomitant soil-transmitted helminth infections [ Time Frame: 14-21 days after treatment ]
    CRs and LRRs will be calculated for T. trichiura, A. lumbricoides and hookworm infections as described in primary and secondary outcome.

  3. Number of participants reporting adverse events [ Time Frame: 14-21 days after treatment ]
    Subjects will be kept for observation for at least 3 hours following treatment for any acute AEs. If there is any abnormal finding, the local study physician will perform a full clinical, physical and biochemical examination and findings will be recorded. An emergency kit will be available on site to treat any medical conditions that warrant urgent medical intervention. In addition patients will also be interviewed 3 and 24 hours and again 3 weeks after treatment about the occurrence of AEs. A standardized symptom questionnaire is used, that includes the recording of headache, abdominal pain, itching, nausea, vomiting, diarrhea, allergic reaction as well as any further mentioned event by the participant.

  4. Maximum concentration (Cmax) of moxidectin in adults [ Time Frame: 0, 2, 4, 8, 24, and 72 hours, 7 and 21 days post treatment ]
    Upon oral intake moxidectin levels in blood will be quantified with time using a micro sampling device. Moxidectin will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 5 ng/ml. The PK analysis will be undertaken fitting a structural compartmental PK model.

  5. Time to reach Cmax (tmax) of moxidectin in adults [ Time Frame: 0, 2, 4, 8, 24, and 72 hours, 7 and 21 days post treatment ]
    Upon oral intake moxidectin levels in blood will be quantified with time using a micro sampling device. Moxidectin will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 5 ng/ml. The PK analysis will be undertaken fitting a structural compartmental PK model.

  6. Area under the curve (AUC) of moxidectin in adults [ Time Frame: 0, 2, 4, 8, 24, and 72 hours, 7 and 21 days post treatment ]
    Upon oral intake moxidectin levels in blood will be quantified with time using a micro sampling device. Moxidectin will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 5 ng/ml. The PK analysis will be undertaken fitting a structural compartmental PK model.

  7. Elimination half life (t1/2) of moxidectin in adults [ Time Frame: 0, 2, 4, 8, 24, and 72 hours, 7 and 21 days post treatment ]
    Upon oral intake moxidectin levels in blood will be quantified with time using a micro sampling device. Moxidectin will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 5 ng/ml. The PK analysis will be undertaken fitting a structural compartmental PK model.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (≥ 18 years) infected with S. stercoralis
  • Absence of major systemic illnesses
  • Written informed consent signed by individual

Exclusion Criteria:

  • Any abnormal medical conditions or chronic disease
  • Negative diagnostic result for S. stercoralis
  • No written informed consent by individual.
  • Pregnant and lactating women.
  • Recent use of anthelmintic drug (within past 4 weeks), attending other clinical trials during the study
  • Known allergy to study medications (i.e. moxidectin, ivermectin)
  • Currently taking medications with known interaction (i.e. for warfarin)

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): NCT04056325


Contacts
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Contact: Jennifer Jennifer, Prof. Dr. +41 61 284-8218 jennifer.keiser@swisstph.ch
Contact: Somphou Sayasone, Dr. +856-20-5567 9603 somphou.sayasone@swisstph.ch

Locations
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Cambodia
National Centre for Parasitology, Entomology and Malaria Control
Phnom Penh, Cambodia
Lao People's Democratic Republic
National Institute of Public Health
Vientiane, Lao People's Democratic Republic
Sponsors and Collaborators
Jennifer Keiser
National Institute of Public Health, Vientiane, Laos
National Centre for Parasitology, Entomology and Malaria Control, Cambodia
Investigators
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Principal Investigator: Jennifer Jennifer, Prof. Dr. STPH

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Responsible Party: Jennifer Keiser, Prof. Jennifer Keiser, PhD, Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT04056325     History of Changes
Other Study ID Numbers: 3
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ivermectin
Strongyloidiasis
Rhabditida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Milbemycin
Antiparasitic Agents
Anti-Infective Agents
Anthelmintics
Antinematodal Agents