Randomized trial of Ivermectin/Albendazole vs. Ivermectin alone

Randomized clinical trail comparing treatment with Albendazole and Ivermectin to Ivermectin alone for Onchocerciasis.

Sites

In progress
Target completion date: 31 Mar 2017
Sample size: 272
Implementation partner(s): CWRU (Kazura/King) | KNUST (Debrah) | Univ. Bonn (Hoerauf)

In progress
Target completion date: 31 Dec 2017
Sample size: 375
Implementation partner(s): CWRU (Kazura/King) | OCRC (Opoku)

Notes

First Trial (Adansi South): CWRU, KNUST, Ghana-Bonn Univ., Germany - ISRCTN50035143 

  • Arm 1 (comparator): IVM 200 μg/kg body weight given at 0, 12 and 24 months; vitamin pills given at 6 and 18 months
  • Arm 2: IVM 200 μg/kg plus ALB 800 mg (regardless of weight) given at 0, 6, 12, 18, and 24 months
  • Arm 3: IVM 200 μg/kg plus ALB 800 mg given at 0, 12 and 24 months; vitamin pills at given at 6 and 18 months
  • Arm 4: IVM 200 μg/kg given 0, 6, 12, 18, and 24 months

Status:

Subjects screened-completed 3Q2012

Complete patients enrollement -1Q/2013

1st treatment - Feb/April 2013

2nd treatment - August /October 2013

3rd treatment - March/April 2014

Expected Trial Completion-1Q2017

 

Second trial (Nkwanta): CWRU and OCRC, Hohoe Ghana - NCT02078024

  • Arm 1 (comparator): IVM 200 μg/kg body weight given at 0, 12 and 24 months; vitamin pills given at 6 and 18 months
  • Arm 2: IVM 200 μg/kg plus ALB 800 mg (regardless of weight) given at 0, 6, 12, 18, and 24 months
  • Arm 3: IVM 200 μg/kg plus ALB 800 mg given at 0, 12 and 24 months; vitamin pills at given at 6 and 18 months
  • Arm 4: IVM 200 μg/kg given 0, 6, 12, 18, and 24 months
  • Arm 5: IVM 200 μg/kg plus ALB 400 mg given at 0, 6, 12, 18, and 24 months

Status:

Recruitment completed -3Q 2015 

Trial initiation -3Q 2015

Expected Trial completion -4Q2017

 

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