Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Introduction of National Mass Drug Administration Campaign and failure to identify appropriate participants.)
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Neil French, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01213576
First received: September 30, 2010
Last updated: February 26, 2015
Last verified: February 2015
Results First Received: February 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Albendazole 400mg and Ivermectin 200mcg/kg Annually

Once a year treatment

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

Albendazole 800mg and Ivermectin 400mcg/kg Annually

Once a year treatment

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

Albendazole 400mg and Ivermectin 200mcg/kg Biannually

Twice a year

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

Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually

Twice a year

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


Participant Flow:   Overall Study
    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  
STARTED     18     17     18     17  
COMPLETED     15     13     13     13  
NOT COMPLETED     3     4     5     4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Albendazole 400mg and Ivermectin 200mcg/kg Annual Albendazole 400mg and ivermectin 200mcg/kg: 400 mg orally given once a year
Albendazole 800mg and Ivermectin 400mcg/kg Annual Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg orally given once a year
Albendazole 400mg and Ivermectin 200mcg/kg Biannual Albendazole 400mg and ivermectin 200mcg/kg given twice a year
Albendazole 800mg and Ivermectin 400mcg/kg Bi-annual Albendazole 800mg and ivermectin 400mcg/kg given twice a year
Total Total of all reporting groups

Baseline Measures
    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  
Number of Participants  
[units: participants]
  18     17     18     17     70  
Age  
[units: years]
Median ( Full Range )
  32.5  
  ( 21 to 50 )  
  31  
  ( 20 to 53 )  
  27.5  
  ( 18 to 55 )  
  35  
  ( 20 to 54 )  
  33  
  ( 18 to 55 )  
Gender  
[units: participants]
         
Female     3     6     7     7     23  
Male     15     11     11     10     47  
Region of Enrollment  
[units: participants]
         
Malawi     18     17     18     17     70  
Microfilarial count /uL  
[units: microfilaria/uL]
Geometric Mean ( Full Range )
  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  
[units: participants]
  0     0     0     0     0  
Eosinophil count  
[units: cells/uL]
Geometric Mean ( Full Range )
  1300  
  ( 1000 to 1700 )  
  1400  
  ( 1000 to 1900 )  
  1600  
  ( 1100 to 2100 )  
  1100  
  ( 900 to 1500 )  
  1300  
  ( 1000 to 1800 )  



  Outcome Measures
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1.  Primary:   Number of Participants Achieving Microfilarial Clearance   [ Time Frame: 12 months ]

2.  Secondary:   Number of Participants With Microfilarial Clearance at 24 Months of Follow up   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Professor Neil French
Organization: University of Liverpool
phone: +441517959630
e-mail: french@liv.ac.uk


No publications provided


Responsible Party: Neil French, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01213576     History of Changes
Other Study ID Numbers: FED-311207
Study First Received: September 30, 2010
Results First Received: February 10, 2015
Last Updated: February 26, 2015
Health Authority: Malawi: National Health Sciences Research Committee