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Trial record 21 of 50 for:    "Elephantiasis" | "Anti-Infective Agents"

Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi (FED)

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ClinicalTrials.gov Identifier: NCT01213576
Recruitment Status : Terminated (Introduction of National Mass Drug Administration Campaign and failure to identify appropriate participants.)
First Posted : October 4, 2010
Results First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Neil French, London School of Hygiene and Tropical Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphatic Filariasis
Interventions Drug: Albendazole 400mg and ivermectin 200mcg/kg
Drug: Albendazole and ivermectin
Drug: albendazole 800mg and ivermectin 400mcg/kg bi-annually
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Albendazole 400mg and Ivermectin 200mcg/kg Annually Albendazole 800mg and Ivermectin 400mcg/kg Annually Albendazole 400mg and Ivermectin 200mcg/kg Biannually Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually
Hide Arm/Group Description

Once a year treatment

Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral

Once a year treatment

Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral

Twice a year

albendazole 400mg and ivermectin 200mcg/kg given twice a year

Twice a year

Albendazole 800mg and ivermectin 400mcg/kg given twice a year

Period Title: Overall Study
Started 18 17 18 17
Completed 15 13 13 13
Not Completed 3 4 5 4
Arm/Group Title Albendazole 400mg and Ivermectin 200mcg/kg Annual Albendazole 800mg and Ivermectin 400mcg/kg Annual Albendazole 400mg and Ivermectin 200mcg/kg Biannual Albendazole 800mg and Ivermectin 400mcg/kg Bi-annual Total
Hide Arm/Group Description Albendazole 400mg and ivermectin 200mcg/kg: 400 mg orally given once a year Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg orally given once a year Albendazole 400mg and ivermectin 200mcg/kg given twice a year Albendazole 800mg and ivermectin 400mcg/kg given twice a year Total of all reporting groups
Overall Number of Baseline Participants 18 17 18 17 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants 17 participants 18 participants 17 participants 70 participants
32.5
(21 to 50)
31
(20 to 53)
27.5
(18 to 55)
35
(20 to 54)
33
(18 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 18 participants 17 participants 70 participants
Female
3
  16.7%
6
  35.3%
7
  38.9%
7
  41.2%
23
  32.9%
Male
15
  83.3%
11
  64.7%
11
  61.1%
10
  58.8%
47
  67.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Malawi Number Analyzed 18 participants 17 participants 18 participants 17 participants 70 participants
18 17 18 17 70
Microfilarial count /uL  
Geometric Mean (Full Range)
Unit of measure:  microfilaria/uL
Number Analyzed 18 participants 17 participants 18 participants 17 participants 70 participants
464.7
(250.1 to 863.4)
338.7
(198.7 to 577.4)
204.5
(204.5 to 287.8)
264.7
(175.0 to 400.4)
298.6
(207.3 to 389.4)
HIV status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 18 participants 17 participants 70 participants
0 0 0 0 0
Eosinophil count  
Geometric Mean (Full Range)
Unit of measure:  cells/uL
Number Analyzed 18 participants 17 participants 18 participants 17 participants 70 participants
1300
(1000 to 1700)
1400
(1000 to 1900)
1600
(1100 to 2100)
1100
(900 to 1500)
1300
(1000 to 1800)
1.Primary Outcome
Title Number of Participants Achieving Microfilarial Clearance
Hide Description Microfilaria clearance will be assessed in regard to dosage as well as frequency of treatment. Microfilarial clearance is defined by non-detection of microfilaria in the night blood sample.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non detectable microfilaria at follow up
Arm/Group Title Albendazole 400mg and Ivermectin 200mcg/kg Annually Albendazole 800mg and Ivermectin 400mcg/kg Annually Albendazole 400mg and Ivermectin 200mcg/kg Biannually Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually
Hide Arm/Group Description:

Once a year treatment

Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral

Once a year treatment

Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral

Twice a year

albendazole 400mg and ivermectin 200mcg/kg given twice a year

Twice a year

Albendazole 800mg and ivermectin 400mcg/kg given twice a year

Overall Number of Participants Analyzed 18 17 18 17
Measure Type: Number
Unit of Measure: participants
15 14 13 17
2.Secondary Outcome
Title Number of Participants With Microfilarial Clearance at 24 Months of Follow up
Hide Description Microfilaria will be detected using the nucleopore filtration technique and analysed according to the respective treatment arms at the 24 month time point. Microfilarial clearance will be defined by non-detection of microfilaria in the night blood sample
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat, with last result carried forward in the case of missing visit
Arm/Group Title Albendazole 400mg and Ivermectin 200mcg/kg Annually Albendazole 800mg and Ivermectin 400mcg/kg Annually Albendazole 400mg and Ivermectin 200mcg/kg Biannually Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually
Hide Arm/Group Description:

Once a year treatment

Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral

Once a year treatment

Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral

Twice a year

albendazole 400mg and ivermectin 200mcg/kg given twice a year

Twice a year

Albendazole 800mg and ivermectin 400mcg/kg given twice a year

Overall Number of Participants Analyzed 18 17 18 17
Measure Type: Number
Unit of Measure: participants
17 17 14 17
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Albendazole 400mg and Ivermectin 200mcg/kg Annually Albendazole 800mg and Ivermectin 400mcg/kg Annually Albendazole 400mg and Ivermectin 200mcg/kg Biannually Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually
Hide Arm/Group Description

Once a year treatment

Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral

Once a year treatment

Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral

Twice a year

albendazole 400mg and ivermectin 200mcg/kg given twice a year

Twice a year

Albendazole 800mg and ivermectin 400mcg/kg given twice a year

All-Cause Mortality
Albendazole 400mg and Ivermectin 200mcg/kg Annually Albendazole 800mg and Ivermectin 400mcg/kg Annually Albendazole 400mg and Ivermectin 200mcg/kg Biannually Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Albendazole 400mg and Ivermectin 200mcg/kg Annually Albendazole 800mg and Ivermectin 400mcg/kg Annually Albendazole 400mg and Ivermectin 200mcg/kg Biannually Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Albendazole 400mg and Ivermectin 200mcg/kg Annually Albendazole 800mg and Ivermectin 400mcg/kg Annually Albendazole 400mg and Ivermectin 200mcg/kg Biannually Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/18 (27.78%)   7/17 (41.18%)   6/18 (33.33%)   4/17 (23.53%) 
General disorders         
Fever   2/18 (11.11%)  4/17 (23.53%)  3/18 (16.67%)  1/17 (5.88%) 
headache   3/18 (16.67%)  4/17 (23.53%)  4/18 (22.22%)  2/17 (11.76%) 
joint pains  2/18 (11.11%)  1/17 (5.88%)  3/18 (16.67%)  2/17 (11.76%) 
abdominal pains   1/18 (5.56%)  2/17 (11.76%)  1/18 (5.56%)  1/17 (5.88%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Neil French
Organization: University of Liverpool
Phone: +441517959630
EMail: french@liv.ac.uk
Layout table for additonal information
Responsible Party: Neil French, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01213576     History of Changes
Other Study ID Numbers: FED-311207
First Submitted: September 30, 2010
First Posted: October 4, 2010
Results First Submitted: February 10, 2015
Results First Posted: February 27, 2015
Last Update Posted: February 27, 2015