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Trial record 32 of 38 for:    "Elephantiasis" | "Anthelmintics"

Post-treatment Effects of Ivermectin (IVM) or Diethylcarbamazine (DEC) in Loiasis

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ClinicalTrials.gov Identifier: NCT01593722
Recruitment Status : Completed
First Posted : May 8, 2012
Results First Posted : November 9, 2016
Last Update Posted : November 9, 2016
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Loiasis
Interventions Drug: Diethylcarbamazine
Drug: Ivermectin
Enrollment 155
Recruitment Details Of the155 subjects recruited, 92 were eligible for screening and signed consent. Thirty had loiasis, of which 16 were excluded because their microfilarial counts were >5000 mf/mL. One subject was excluded because of age and one declined to participate. The remaining 12 patients were enrolled in the treatment arm of the study.
Pre-assignment Details  
Arm/Group Title Single Dose DEC Single Dose IVM
Hide Arm/Group Description

diethylcarbamazine 8 mg/kg single oral dose

Diethylcarbamazine: single dose

ivermectin 200 mcg/kg single oral dose

Ivermectin: single dose

Period Title: Overall Study
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title Single Dose DEC SIngle Dose IVM Total
Hide Arm/Group Description

diethylcarbamazine 8 mg/kg single oral dose

Diethylcarbamazine: single dose

ivermectin 200 mcg/kg single oral dose

Ivermectin: single dose

Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
44.5
(20 to 60)
38.5
(25 to 53)
44.5
(20 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
2
  33.3%
2
  33.3%
4
  33.3%
Male
4
  66.7%
4
  66.7%
8
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Cameroon Number Analyzed 6 participants 6 participants 12 participants
6 6 12
Absolute eosinophil count  
Geometric Mean (Full Range)
Unit of measure:  Cells x 10^9/L
Number Analyzed 6 participants 6 participants 12 participants
3.27
(2.3 to 5.76)
1.76
(1.05 to 2.35)
2.40
(1.05 to 5.76)
Loa microfilarial count  
Geometric Mean (Full Range)
Unit of measure:  Mf/ml
Number Analyzed 6 participants 6 participants 12 participants
1074
(200 to 20380)
355
(60 to 2300)
618
(60 to 20380)
1.Primary Outcome
Title The Peak % of Baseline Eosinophil Count Measured During the First 7 Days Post-treatment.
Hide Description [Not Specified]
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diethylcarbamazine Ivermectin
Hide Arm/Group Description:

diethylcarbamazine 8 mg/kg single oral dose

Diethylcarbamazine: single dose

ivermectin 200 mcg/kg single oral dose

Ivermectin: single dose

Overall Number of Participants Analyzed 6 6
Geometric Mean (Full Range)
Unit of Measure: percentage of baseline
196
(112 to 224)
165
(124 to 257)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diethylcarbamazine, Ivermectin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title The Frequency of Adverse Events
Hide Description Symptoms, signs and laboratory abnormalities occurring in the 7 days post-treatment
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diethylcarbamazine Ivermectin
Hide Arm/Group Description:

diethylcarbamazine 8 mg/kg single oral dose

Diethylcarbamazine: single dose

ivermectin 200 mcg/kg single oral dose

Ivermectin: single dose

Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: events
115 103
3.Secondary Outcome
Title Eosinophil Activation
Hide Description Levels of surface marker expression on eosinophils
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose DEC Single Dose IVM
Hide Arm/Group Description:

diethylcarbamazine 8 mg/kg single oral dose

Diethylcarbamazine: single dose

ivermectin 200 mcg/kg single oral dose

Ivermectin: single dose

Overall Number of Participants Analyzed 6 6
Geometric Mean (Full Range)
Unit of Measure: % cells expressing CD69
%CD69 expression on eosinophils at peak
21.5
(6.1 to 79.7)
21.5
(8.4 to 94)
%CD69 expression on eosinophils at baseline
1.7
(0.1 to 4.2)
1.5
(0.1 to 4.6)
4.Secondary Outcome
Title Proportion of Subjects Who Clear Microfilaremia
Hide Description [Not Specified]
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diethylcarbamazine Ivermectin
Hide Arm/Group Description:

diethylcarbamazine 8 mg/kg single oral dose

Diethylcarbamazine: single dose

ivermectin 200 mcg/kg single oral dose

Ivermectin: single dose

Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
3 0
5.Other Pre-specified Outcome
Title Treatment Efficacy
Hide Description Proportion of subjects without signs of infection
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Microfilarial count and symptoms
Arm/Group Title Diethylcarbamazine Ivermectin
Hide Arm/Group Description:

diethylcarbamazine 8 mg/kg single oral dose

Diethylcarbamazine: single dose

ivermectin 200 mcg/kg single oral dose

Ivermectin: single dose

Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
0 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diethylcarbamazine Ivermectin
Hide Arm/Group Description

diethylcarbamazine 8 mg/kg single oral dose

Diethylcarbamazine: single dose

ivermectin 200 mcg/kg single oral dose

Ivermectin: single dose

All-Cause Mortality
Diethylcarbamazine Ivermectin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Diethylcarbamazine Ivermectin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diethylcarbamazine Ivermectin
Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   6/6 (100.00%) 
Cardiac disorders     
Palpitations *  0/6 (0.00%)  1/6 (16.67%) 
Eye disorders     
Blurry vision *  3/6 (50.00%)  1/6 (16.67%) 
Gastrointestinal disorders     
Diarrhea *  1/6 (16.67%)  3/6 (50.00%) 
Nausea/vomiting *  2/6 (33.33%)  2/6 (33.33%) 
Abdominal pain *  2/6 (33.33%)  2/6 (33.33%) 
General disorders     
Fatigue *  2/6 (33.33%)  0/6 (0.00%) 
Infections and infestations     
Eyeworm *  1/6 (16.67%)  2/6 (33.33%) 
Musculoskeletal and connective tissue disorders     
Myalgia/arthralgia *  2/6 (33.33%)  5/6 (83.33%) 
Nervous system disorders     
Headache *  4/6 (66.67%)  4/6 (66.67%) 
Paresthesia *  1/6 (16.67%)  1/6 (16.67%) 
Dizziness *  4/6 (66.67%)  2/6 (33.33%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea *  2/6 (33.33%)  0/6 (0.00%) 
Cough *  3/6 (50.00%)  1/6 (16.67%) 
Chest pain *  3/6 (50.00%)  3/6 (50.00%) 
Skin and subcutaneous tissue disorders     
Calabar swelling *  3/6 (50.00%)  2/6 (33.33%) 
Rash *  3/6 (50.00%)  1/6 (16.67%) 
Hives *  0/6 (0.00%)  1/6 (16.67%) 
Pruritus *  3/6 (50.00%)  4/6 (66.67%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Amy Klion
Organization: Laboratory of Parasitic Diseases, NIAID, NIH
Phone: 301-435-8903
EMail: aklion@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01593722     History of Changes
Other Study ID Numbers: 999912117
12-I-N117 ( Other Identifier: NIAID IRB )
First Submitted: May 5, 2012
First Posted: May 8, 2012
Results First Submitted: December 2, 2015
Results First Posted: November 9, 2016
Last Update Posted: November 9, 2016