A Phase 2/3 interventional study of Albendazole and Ivermectin fixed dose coformulation and Albendazole in Helminthes; Infestation, Intestinal, sponsored by Barcelona Institute for Global Health. Terminated at 3 sites in 3 countries. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Barcelona Institute for Global Health · Phase 2/3, Interventional, and Treatment
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.
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 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.
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 2: Single dose of a tablet of FDC 400mg-18mg or 400mg-9mg.
Treatment Arm 3: Daily dose of a tablet of FDC 400mg-18mg or 400mg9mg for 3 days.
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
37 studies on the registry are indexed under Helminthiasis; 2 are open to participants now.
This study's enrollment of 1,001 is above the median of 326 across 29 interventional studies indexed under Helminthiasis.
Browse Helminthiasis studies →Barcelona Institute for Global Health is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Albendazole 400 mg single dose
Drug: Albendazole
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
Combination Product: Albendazole and Ivermectin fixed dose coformulation
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.
Combination Product: Albendazole and Ivermectin fixed dose coformulation
400 mg Albendazole - 9 mg Ivermectin OR 400 mg Albendazole - 18 mg Ivermectin
Albendazole 400mg single dose
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).
Time frame: 21 days
Frequency of Related Adverse Events
Proportions of participants presenting at least one treatment-related adverse event by arm
Time frame: 21 days postreatment
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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
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.
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.
Time frame: 21 days
| Milestone | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) |
|---|---|---|---|
| Started | 30 | 51 | 54 |
| Received any study drug after randomization | 27 | 50 | 51 |
| Completed | 24 | 48 | 51 |
| Not completed | 6 | 3 | 3 |
| Withdrew: Eligibility criteria | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 6 | 2 | 3 |
| Milestone | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) |
|---|---|---|---|
| Started | 213 | 330 | 323 |
| Received any study drug after randomization | 213 | 330 | 323 |
| Completed | 206 | 326 | 319 |
| Not completed | 7 | 4 | 4 |
| Withdrew: Withdrawal by subject | 6 | 4 | 4 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
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).
| Participants | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) |
|---|---|---|---|
| Cure Rate for T. Trichiura (CR) | 47 | 208 | 247 |
Proportions of participants presenting at least one treatment-related adverse event by arm
| Participants | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) |
|---|---|---|---|
| ITT Phase II and Phase III | 34 | 75 | 88 |
| ITT Phase II | 3 | 8 | 10 |
| ITT Phase III | 31 | 67 | 78 |
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.
| Percentage of reduction | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) |
|---|---|---|---|
| Egg Reduction Rate for T. Trichiura (ERR) | 83.4 (73.7 to 89.8) | 99.2 (98.9 to 99.5) | 99.9 (99.8 to 99.9) |
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).
| Participants | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) |
|---|---|---|---|
| Cure Rate for for Hookworm (CR) | 69 | 99 | 114 |
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.
| Percentage of reduction | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) |
|---|---|---|---|
| Egg Reduction Rate for Hookworm (ERR) | 97.8 (96.6 to 98.7) | 99.0 (98.2 to 99.4) | 99.8 (99.5 to 99.9) |
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).
| Participants | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) |
|---|---|---|---|
| Cure Rates for for S. Stercoralis | 13 | 38 | 41 |
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).
| Participants | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) |
|---|---|---|---|
| Cure Rate for T. Trichiura (CR) by qPCR | 55 | 152 | 188 |
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.
No measurements were reported for this outcome.
Collected over For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication.. Non-serious events are listed at a 0.5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Albendazole | 0/243 (0%) | 0/243 (0%) | 50/243 (20.6%) |
| Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | 0/381 (0%) | 0/381 (0%) | 99/381 (26%) |
| Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) | 0/377 (0%) | 0/377 (0%) | 107/377 (28.4%) |
| Event | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) |
|---|---|---|---|
| Abdominal painGastrointestinal disorders | 23/243 | 52/381 | 47/377 |
| HeadacheNervous system disorders | 7/243 | 20/381 | 14/377 |
| NauseaGastrointestinal disorders | 2/243 | 6/381 | 17/377 |
| DiarrhoeaGastrointestinal disorders | 5/243 | 17/381 | 12/377 |
| VomitingGastrointestinal disorders | 4/243 | 10/381 | 12/377 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/243 | 4/381 | 10/377 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 4/243 | 2/381 | 5/377 |
| Parasitic gastroenteritisGastrointestinal disorders | 3/243 | 3/381 | 4/377 |
| Upper respiratory track infectionRespiratory, thoracic and mediastinal disorders | 2/243 | 4/381 | 2/377 |
The variation in participant numbers is attributed to the differing allocation ratios for each infection. Specifically, the allocation rate was 1:2:2 for Trichuris, 1:1:1 for hookworm, and 2:5:5 for S. stercoralis, reflecting the study's design for each pathogen
| Age, Continuous(Years) | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) | Total |
|---|---|---|---|---|
| Phase II | 9.0 ± 2.55 | 8.9 ± 2.66 | 9.2 ± 2.74 | 9.1 ± 2.65 |
| Phase III | 11.4 ± 3.08 | 11.2 ± 3.05 | 11.3 ± 3.24 | 11.3 ± 3.13 |
| Sex: Female, Male(Participants) | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) | Total |
|---|---|---|---|---|
| Phase II — Female | 20 | 28 | 31 | 79 |
| Phase II — Male | 10 | 23 | 23 | 56 |
| Phase III — Female | 113 | 165 | 179 | 457 |
| Phase III — Male | 100 | 165 | 144 | 409 |
| Race (NIH/OMB)(Participants) | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) | Total |
|---|---|---|---|---|
| Phase II — American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Phase II — Asian | 0 | 0 | 0 | 0 |
| Phase II — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Phase II — Black or African American | 30 | 51 | 54 | 135 |
| Phase II — White | 0 | 0 | 0 | 0 |
| Phase II — More than one race | 0 | 0 | 0 | 0 |
| Phase II — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Phase III — American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Phase III — Asian | 0 | 0 | 0 | 0 |
| Phase III — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Phase III — Black or African American | 213 | 330 | 323 | 866 |
| Phase III — White | 0 | 0 | 0 | 0 |
| Phase III — More than one race | 0 | 0 | 0 | 0 |
| Phase III — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) | Total |
|---|---|---|---|---|
| Ethiopia — Phase II | 0 | 0 | 0 | 0 |
| Ethiopia — Phase III | 96 | 107 | 104 | 307 |
| Kenya — Phase II | 30 | 51 | 54 | 135 |
| Kenya — Phase III | 84 | 158 | 155 | 397 |
| Mozambique — Phase II | 0 | 0 | 0 | 0 |
| Mozambique — Phase III | 33 | 65 | 64 | 162 |
| Number of subjects positive for infection with T. trichiura(Participants) | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) | Total |
|---|---|---|---|---|
| Phase II | 30 | 51 | 54 | 135 |
| Phase III | 101 | 200 | 200 | 501 |
| Eggs per gram (EPG) detected by Kato-Katz technique in participants infected with T. trchiura(Eggs per gram of stool) | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) | Total |
|---|---|---|---|---|
| Phase II | 113.0 ± 1.2 | 137.4 ± 1.5 | 159.4 ± 1.4 | 139.6 ± 1.4 |
| Phase III | 128.0 ± 1.5 | 124.2 ± 1.4 | 121.6 ± 1.5 | 123.9 ± 1.5 |
| Number of subjects positive for infection with Hookworms(Participants) | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) | Total |
|---|---|---|---|---|
| Phase II | 2 | 4 | 4 | 10 |
| Phase III | 106 | 124 | 120 | 350 |
| Eggs per gram (EPG) detected by Kato-Katz technique in participants infected with hookworm(Eggs per gram of stool) | Albendazole | Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) | Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) | Total |
|---|---|---|---|---|
| Phase II | 42.6 ± 0.2 | 527.3 ± 1.5 | 93.0 ± 2.3 | 159.2 ± 1.9 |
| Phase III | 116.6 ± 1.3 | 118.2 ± 1.3 | 112.9 ± 1.4 | 115.9 ± 1.3 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Analytic code
Time frame: Data is already available upon request to IDDO
Access criteria: All data sharing request received by IDDO will be addressed to the project consortium members who will approve/reject the data sharing based on the relevance of the proposal.
Data sharing details ↗ · www.iddo.org
Ran from Jan 2022 to primary completion in Mar 2023, 14 months.
Results were first posted in Sep 2025, 2 years 6 months after primary completion.
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Barcelona Institute for Global Health