Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05124691 |
| Other study ID # |
ALIVE |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2022 |
| Est. completion date |
March 24, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Barcelona Institute for Global Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this clinical trial is to evaluate a fixed-dose co-formulation (FDC) of
ivermectin and albendazole for the treatment of all Soil Transmitted helminths (STH). The
current strategy to control STH in endemic areas is mass administration of albendazole or
mebendazole, mainly to pre-school and school-aged children.
Although this treatment works well for some STH species, efficacy against Trichuris trichiura
is poor and it is not effective Strongyloides stercoralis. Thus new drugs or drug
combinations are an urgent priority to increase the effectiveness of control programmes.
Furthermore, the World Health Organisation has recommended combination therapy of ivermectin
with albendazole. The trial proposed, is an adaptive phase II/III trial where the phase II
component will evaluate the safety of the FDC as a single dose or 3-day single dose regimen
for the treatment of T. trichiura in paediatric population. After analysis of the safety
results the phase III trial will be executed to evaluate the efficacy of the FDC as a single
dose or 3-day single dose regimen compared to the standard single dose regimen of ALB (400
mg) for the treatment of T. trichiura, hookworm and S. stercoralis in paediatric and young
adult population. The estimated total sample size for the adaptive design (phase II and III
component) is 1223 participants. Of these, 126 will be enrolled in the phase II and 1097 in
the phase III components respectively in an adaptive trial design.
Description:
An adaptive phase II/III clinical trial to evaluate the Safety and Efficacy of a Single Day
or 3-day Single Dose of an ALBENDAZOLE-IVERMECTIN Coformulation vs ALBENDAZOLE for the
Treatment of Soil-Transmitted Helminth Infections. The estimated total sample size for the
adaptive design (phase II and III components) is 1223 participants. Of these, 126 will be
enrolled in the phase II and 1097 in the phase III components.
Phase II component (Kenya only)
Unicentric, 3-arm, parallel, open-label, individually randomised, phase II trial to determine
in three weight groups, the safety of the ALBENDAZOLEIVERMECTIN Co-formulation given as a
Single Day or 3-day Single Dose regimen for the treatment of Trichuris trichiura in children
and young adult aged between 5 to 18 years. Estimated sample size: 126 participants
Participants will be stratified in three different weight groups in order to gradually
increase the dose of ivermectin in the Fixed Dose Co-formulation (FDC):
- Group 1 (38 participants): with body weight of 23-<30 Kg will receive 300-391 µg/Kg IVM
(FDC 400mg-9mg) or ALB
- Group 2 (38 participants): with body weight of 30-45 Kg will receive 400-600 µg/Kg IVM
(FDC 400mg-18mg) or ALB.
- Group 3 (50 participants): with body weight of 15-23 Kg will receive 391-600 µg/Kg IVM
(FDC 400mg-9mg) or ALB. Where FDC stands for Fixed Dose Co-formulation and ALB stands
for Albendazole. Then, the participants will be allocated to one of the three study arms
with unequal probability (ALB: p=0.2, n=26; FDCx1: p=0.4, n=50; FDCx3: p=0.4, n=50)
starting with group 1.
- Treatment Arm 1: Single dose of a tablet of ALBENDAZOLE 400 mg (active control
arm).
- Treatment Arm 2: Single dose of a tablet of ALBENDAZOLEIVERMECTIN Co-formulation.
- Treatment Arm 3: Daily dose of a tablet of ALBENDAZOLE-IVERMECTIN Co-formulation
for 3 consecutive days.
Phase III Component
A multi-centre, 3-arm, parallel, open-label, randomised, phase III trial to compare safety
and efficacy of the active control arm (current standard of care) against 2 experimental arms
for the treatment of T. trichiura, hookworm and S. stercoralis, in children and young adult
aged between 5-18 years in three subSaharan African countries (Ethiopia, Kenya and
Mozambique) We hypothesise that the FDC of Ivermectin (IVM) and ALB either at single or 3-
day regimens will be more effective against some species of Soil Transmitted Helminths (STH)
(T. trichiura, hookworm and S. stercoralis) compared to the current use of a single dose
regimen of 400mg ALB. Estimated sample size: 1097 participants Participants will be randomly
allocated with unequal probability, according to the specific expected cure rate by treatment
and specie, to one of the three study treatment arms.
- Treatment Arm 1: Single dose of a tablet of ALB 400 mg (active control arm).
- Treatment Arm 2: Single dose of a tablet of FDC 400mg-18mg or 400mg-9mg.
- For participants <45 kg of body weight at baseline: FDC of 400mg ALB- 9mg IVM.
- For participants ≥45 kg of body weight at baseline: FDC of 400mg ALB-18mg IVM.
- Treatment Arm 3: Daily dose of a tablet of FDC 400mg-18mg or 400mg9mg for 3 days.
- For participants <45 kg of body weight at baseline: FDC of 400mg ALB-9mg IVM.
- For participants ≥45 kg of body weight at baseline: FDC of 400mg ALB- 18mg IVM.
In the phase III component, allocation of participants to study arms will be done by block
randomization and stratified by the species of STH. Treatment allocation for each study
participant will be concealed in opaque sealed envelope that will be opened only after
enrolment. Study participants will be assigned a unique number linked to the allocated
treatment group.
The phase II and III trial components comprise of a screening phase, an enrolment phase, a
treatment phase, a post-treatment phase with follow-up visits, and early
withdrawal/end-of-study evaluations. Participants recruited in Mozambique will be offered to
be tested for HIV serostatus due to the high HIV prevalence in the country, but the result
will not determine the participant's eligibility. In Kenya and Ethiopia, the low HIV
prevalence does not justify HIV testing
