Helminthes; Infestation, IntestinalPhase 2/3ALIVENCT05124691
Evaluation of Effectiveness of ALBENDAZOLIVERMECTIN Coformulation vs ALBENDAZOLE for Treatment of Intestinal Worms
A Phase 2/3 study testing Albendazole and Ivermectin fixed dose coformulation and Albendazole in people with Helminthes; Infestation, Intestinal, run by Barcelona Institute for Global Health at 3 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Helminthes; Infestation, Intestinal
- What is being tested?
- Albendazole and Ivermectin fixed dose coformulation and Albendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,001 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 20 Jan 2022to 24 Mar 2023
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Positive infection test by microscopy for at least one of the following STH: T. trichiura, hookworms and/or larvae of S. stercoralis.
- Weight ≥15 Kg.
- Male or female, aged 5 to 18 years.
- Female participants who are ≥12 years old (or female post menarche) must have a negative urine pregnancy test at screening or at the time of randomization.
- Ability to take oral medication and willingness to comply with all study procedures.
- Parental acceptance to participate in the study by obtaining a signed and dated informed consent form approved by the Regulatory authorities. In addition, verbal assent will be obtained from children aged 12-18 years.
Who cannot join
- Intake of ALB, mebendazole and/or IVM, or any potentially interacting drug three months before screening.
- Residence outside the study area or planning to move away in the four weeks following recruitment.
- Epidemiological risk of infection by Loa loa.
- Serious medical illness, per investigator's criteria.
- Any participant's condition that would prevent the appropriate evaluation and followup, as per investigator's criteria.
- Known hypersensitivity to any components of either of the study treatment.
- Positive pregnancy urine test, pregnant or first week postpartum.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Ethiopia1 site
Bahir Dar University, Colleges of Medicine and Health Sciences (BDU-CMHS)
Bahir Dar, P.O. Box 79
Mozambique1 site
Centro de Investigação em Saúde da Manhiça (CISM)
Manhiça, Maputo Province, 1929
About this study
Official title: An Adaptive Phase II/III SingleBlinded, Randomized, MultiCentre, ParallelGroup, Active Controlled, Superiority Study to Evaluate the Safety and Efficacy of a Single Day or 3day Single Dose of an ALBENDAZOLE IVERMECTIN Coformulation vs ALBENDAZOLE for the Treatment of SoilTransmitted Helminth Infections (Trichuris Trichiura, Hookworm, Strongyloides Stercoralis) in Paediatric and Young Adult Population
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.
Read the detailed 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
- Conditions
- Helminthes; Infestation, Intestinal
- Being tested
- Albendazole and Ivermectin fixed dose coformulation, Albendazole
- Keywords
- soil-transmitted helminths, pediatric, adult, albendazole, ivermectin, coformulation
- Medical subject headings
- Helminthiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albendazole and Ivermectin fixed dose coformulationCombination product
400 mg Albendazole - 9 mg Ivermectin OR 400 mg Albendazole - 18 mg Ivermectin
AlbendazoleDrug
Albendazole 400mg single dose
| Study group | Role | What they receive |
|---|---|---|
| Albendazole | Active comparator | Albendazole 400 mg single dose Receives: Drug: Albendazole |
| FDCx1. Albendazole and Ivermectin Fixed Dose Coformulation | Experimental | Single dose of a tablet of FDC 400mg18mg or 400mg9mg. (i) For participants <45 kg of body weight at baseline: FDC of 400mg ALB 9mg IVM. (ii) For participants ≥45 kg of body weight at baseline: FDC of 400mg ALB18mg IVM Receives: Combination Product: Albendazole and Ivermectin fixed dose coformulation |
| FDCx3. Albendazole and Ivermectin Fixed Dose Coformulation 3 days | Experimental | Daily dose of a tablet of FDC 400mg18mg or 400mg 9mg for 3 days. (i)For participants <45 kg of body weight at baseline: FDC of 400mg ALB9mg IVM. (ii) For participants ≥45 kg of body weight at baseline: FDC of 400mg ALB 18mg IVM. Receives: Combination Product: Albendazole and Ivermectin fixed dose coformulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure Rate for T. Trichiura (CR)
For Trichuris trichiura, the cure rate is defined as the proportion of participants who test negative for T. trichiura eggs in the Kato-Katz fecal examination on day 21 post-treatment, relative to the total number of participants infected at baseline (n=636).
Measured: 21 days
Frequency of Related Adverse Events
Proportions of participants presenting at least one treatment-related adverse event by arm
Measured: 21 days postreatment
Secondary outcomes (6)
Egg Reduction Rate for T. Trichiura (ERR)
The Egg Reduction Rate (ERR) is defined as the percentage reduction in the geometric mean (GM) of eggs per gram (EPG) of feces from baseline to post-treatment.
Measured: 21 days
Cure Rate for for Hookworm (CR)
For hookworm, the cure rate is defined as the proportion of participants who test negative for hookworm eggs in the Kato-Katz fecal examination on day 21 post-treatment, relative to the total number of participants infected at baseline in Phase III (n=350).
Measured: 21 days
Egg Reduction Rate for Hookworm (ERR)
The Egg Reduction Rate (ERR) is defined as the percentage reduction in the geometric mean (GM) of eggs per gram (EPG) of feces from baseline to post-treatment.
Measured: 21 days
Cure Rates for for S. Stercoralis
For S. stercoralis, the cure rate is defined as the proportion of participants who test negative for S. stercoralis larvae in the Baermann tesi on day 21 post-treatment, relative to the total number of participants infected at baseline in Phase III (n=97).
Measured: 21 days
Cure Rate for T. Trichiura (CR) by qPCR
For Trichuris trichiura, the cure rate is defined as the proportion of participants who test negative by qPCR (Ct-value>35) on day 21 post-treatment, relative to the total number of participants that were positves at baseline by Kato-Katz and qPCR (n=534).
Measured: 21 days
To Evaluate the Frequency of Known ALB Resistant Alleles in Hookworm and T. Trichiura in the Three Treatment Arms Before and After Treatment.
The original objective as per the protocol was to "To evaluate the frequency of known ALB resistant alleles in hookworm and T. trichiura in the three treatment arms before and after treatment" with the endpoint being "Evaluation of genotypic albendazole resistance in the three arms." This objective was based on the hypothesis that mutations at codons 167, 198, and 200 of the beta-tubulin gene of Trichuris trichiura were associated with resistance. However, since this time, it has become increasingly evident, based on research from us (PMID: 35895348, 39546832, 34563247) and others, that this hypothesis is no longer supported, and that the genetic determinants of resistance in T. trichiura are yet to be discovered. Therefore, we have begun evaluating, using whole genome sequencing, other genetic variants and their association with poor treatment response. This research is exploratory and ongoing. Therefore, the original outcome as defined in the protocol could not be assessed.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start20 Jan 2022
- Primary completion21 Mar 2023
- Study completion24 Mar 2023
Why it stopped: Primary Endpoint met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Helminthes; Infestation, IntestinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelona Institute for Global Health
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Bahir Dar University, Centro de Investigacao em Saude de Manhica, London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute, Laboratorios Liconsa, Universidad de León, European and Developing Countries Clinical Trials Partnership (EDCTP)
- Responsible party
- Sponsor
- Investigators
- Jose Munoz, MD, PhD, Principal investigator, Barcelona institue for Global health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124691
- Sponsor's protocol ID
- ALIVE
- Acronym
- ALIVE
- Status last verified
- Sep 2025
- First submitted
- 16 Nov 2021
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data from the ALIVE clinical trial (phase II and phase III) have been upload to the Infectious Diseases Data Observatory (IDDO). IDDO is a scientifically independent, multi-disciplinary coalition of the global infectious disease and emerging infections communities. Thus, data will be available upon request in a collaborative data repository for verification and re-use.
Publications
Krolewiecki A, Kepha S, Fleitas PE, van Lieshout L, Gelaye W, Messa A Jr, Gandasegui J, Algorta J, Novela V, de Jesus A, Rono M, Degarege D, Bedane D, Mwahanje J, Mandomando I, Mwandawiro C, Enbiale W, Munoz J; Stopping Transmission of Intestinal Parasites (STOP) consortium. Albendazole-ivermectin co-formulation for the treatment of Trichuris trichiura and other soil-transmitted helminths: a randomised phase 2/3 trial. Lancet Infect Dis. 2025 May;25(5):548-559. doi: 10.1016/S1473-3099(24)00669-8. Epub 2025 Jan 10.
PubMed 39805305Krolewiecki A, Enbiale W, Gandasegui J, van Lieshout L, Kepha S, Messa Junior A, Bengtson M, Gelaye W, Escola V, Martinez-Valladares M, Cambra-Pelleja M, Algorta J, Marti-Soler H, Fleitas P, Ballester MR, Doyle SR, Williams NA, Legarda A, Mandomando I, Mwandawiro C, Munoz J. An adaptive phase II/III safety and efficacy randomized controlled trial of single day or three-day fixed-dose albendazole-ivermectin co-formulation versus albendazole for the treatment of Trichuris trichiura and other STH infections. ALIVE trial protocol. Gates Open Res. 2022 May 5;6:62. doi: 10.12688/gatesopenres.13615.1. eCollection 2022.
PubMed 36540062
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Phase II/III SingleBlinded, Randomized, MultiCentre, ParallelGroup, Active Controlled, Superiority Study to Evaluate the Safety and Efficacy of a Single Day or 3day Single Dose of an ALBENDAZOLE IVERMECTIN Coformulation vs ALBENDAZOLE for the Treatment of SoilTransmitted Helminth Infections (Trichuris Trichiura, Hookworm, Strongyloides Stercoralis) in Paediatric and Young Adult Population
- ClinicalTrials.gov ID
- NCT05124691
- Acronym / sponsor ID
- ALIVE / ALIVE
- Conditions
- Helminthes; Infestation, Intestinal
- Keywords
- soil-transmitted helminths, pediatric, adult, albendazole, ivermectin, coformulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary Endpoint met
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- Barcelona Institute for Global HealthUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Bahir Dar University, Centro de Investigacao em Saude de Manhica, London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute, Laboratorios Liconsa, Universidad de León, European and Developing Countries Clinical Trials Partnership (EDCTP)
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 18 Nov 2021 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Albendazole | Active comparator | Drug: AlbendazoleAlbendazole 400 mg single dose |
| FDCx1. Albendazole and Ivermectin Fixed Dose Coformulation | Experimental | Combination Product: Albendazole and Ivermectin fixed dose coformulationSingle dose of a tablet of FDC 400mg18mg or 400mg9mg. (i) For participants <45 kg of body weight at baseline: FDC of 400mg ALB 9mg IVM. (ii) For participants ≥45 kg of body weight at baseline: FDC of 400mg ALB18mg IVM |
| FDCx3. Albendazole and Ivermectin Fixed Dose Coformulation 3 days | Experimental | Combination Product: Albendazole and Ivermectin fixed dose coformulationDaily dose of a tablet of FDC 400mg18mg or 400mg 9mg for 3 days. (i)For participants <45 kg of body weight at baseline: FDC of 400mg ALB9mg IVM. (ii) For participants ≥45 kg of body weight at baseline: FDC of 400mg ALB 18mg IVM. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Positive infection test by microscopy for at least one of the following STH: T. trichiura, hookworms and/or larvae of S. stercoralis.
- Weight ≥15 Kg.
- Male or female, aged 5 to 18 years.
- Female participants who are ≥12 years old (or female post menarche) must have a negative urine pregnancy test at screening or at the time of randomization.
- Ability to take oral medication and willingness to comply with all study procedures.
Key exclusion criteria (7 listed)
- Intake of ALB, mebendazole and/or IVM, or any potentially interacting drug three months before screening.
- Residence outside the study area or planning to move away in the four weeks following recruitment.
- Epidemiological risk of infection by Loa loa.
- Serious medical illness, per investigator's criteria.
- Any participant's condition that would prevent the appropriate evaluation and followup, as per investigator's criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albendazole and Ivermectin fixed dose coformulation400 mg Albendazole - 9 mg Ivermectin OR 400 mg Albendazole - 18 mg Ivermectin | Combination product | FDCx1. Albendazole and Ivermectin Fixed Dose Coformulation, FDCx3. Albendazole and Ivermectin Fixed Dose Coformulation 3 days |
| AlbendazoleAlbendazole 400mg single dose | Drug | Albendazole |
Primary outcome
Cure Rate for T. Trichiura (CR)
Time frame: 21 days
For Trichuris trichiura, the cure rate is defined as the proportion of participants who test negative for T. trichiura eggs in the Kato-Katz fecal examination on day 21 post-treatment, relative to the total number of participants infected at baseline (n=636).
Frequency of Related Adverse Events
Time frame: 21 days postreatment
Proportions of participants presenting at least one treatment-related adverse event by arm
6 secondary outcomes
Egg Reduction Rate for T. Trichiura (ERR)
Time frame: 21 days
Cure Rate for for Hookworm (CR)
Time frame: 21 days
Egg Reduction Rate for Hookworm (ERR)
Time frame: 21 days
Cure Rates for for S. Stercoralis
Time frame: 21 days
Cure Rate for T. Trichiura (CR) by qPCR
Time frame: 21 days
To Evaluate the Frequency of Known ALB Resistant Alleles in Hookworm and T. Trichiura in the Three Treatment Arms Before and After Treatment.
Time frame: 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39805305Krolewiecki A, Kepha S, Fleitas PE, van Lieshout L, Gelaye W, Messa A Jr, Gandasegui J, Algorta J, Novela V, de Jesus A, Rono M, Degarege D, Bedane D, Mwahanje J, Mandomando I, Mwandawiro C, Enbiale W, Munoz J; Stopping Transmission of Intestinal Parasites (STOP) consortium. Albendazole-ivermectin co-formulation for the treatment of Trichuris trichiura and other soil-transmitted helminths: a randomised phase 2/3 trial. Lancet Infect Dis. 2025 May;25(5):548-559. doi: 10.1016/S1473-3099(24)00669-8. Epub 2025 Jan 10.
- Derived from this study: PubMed 36540062Krolewiecki A, Enbiale W, Gandasegui J, van Lieshout L, Kepha S, Messa Junior A, Bengtson M, Gelaye W, Escola V, Martinez-Valladares M, Cambra-Pelleja M, Algorta J, Marti-Soler H, Fleitas P, Ballester MR, Doyle SR, Williams NA, Legarda A, Mandomando I, Mwandawiro C, Munoz J. An adaptive phase II/III safety and efficacy randomized controlled trial of single day or three-day fixed-dose albendazole-ivermectin co-formulation versus albendazole for the treatment of Trichuris trichiura and other STH infections. ALIVE trial protocol. Gates Open Res. 2022 May 5;6:62. doi: 10.12688/gatesopenres.13615.1. eCollection 2022.
- Individual participant dataSharing planned: Yes. All data from the ALIVE clinical trial (phase II and phase III) have been upload to the Infectious Diseases Data Observatory (IDDO). IDDO is a scientifically independent, multi-disciplinary coalition of the global infectious disease and emerging infections communities. Thus, data will be available upon request in a collaborative data repository for verification and re-use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Munoz, MD, PhD principal investigator
Barcelona institue for Global health
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Albendazole and Ivermectin fixed dose coformulation and Albendazole in people with Helminthes; Infestation, Intestinal, run by Barcelona Institute for Global Health at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ethiopia, Kenya, Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure Rate for T. Trichiura (CR) (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05124691, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.