Trial · NCT07045493
Assessing the Safety and Efficacy of a Combination Therapy for STH in PSAC in Bangladesh
NCT07045493, Phase 2, Enrolling by invitation, International Centre for Diarrhoeal Disease Research, Bangladesh
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessing the Safety and Efficacy of a Combination Therapy for STH in PSAC in Bangladesh. Trials, record NCT07045493. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07045493
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessing the Safety and Efficacy of a Combination Therapy for STH in PSAC in Bangladesh
- NCT number
- NCT07045493
- Status
- Enrolling by invitation
- Phases
- Phase 2
- Enrollment
- 110 participants, estimated
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Conditions
- Soil Transmitted Helminth (STH) Infections
- Interventions
- A single dose of Albendazole 400mg + Ivermectin (200 µg/ kg) combination therapy, A single dose of 400 mg Oral Albendazole monotherapy
- First posted
- 2025-07-01
- Last updated
- 2025-08-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Through study completion, an average of 1 year | The investigators will determine the safety of ivermectin and albendazole combination therapy for STH among preschool-age children (ages 2-5 years old) by assessing severe adverse events (SAEs) assessed by CTCAE v4.0. An adverse event will be defined as severe if it causes or contributes to the death or hospitalization for life-threatening conditions or results in persistent or significant disability or incapacity or a medically significant event. Any SAE occurrence for any child will be considered unsafe for that child. |
| Primary | Determine statistically significant effect of combination therapy | 3 weeks, 3 months, 6 months, 9 months, 12 months after baseline enrolment | The investigators will determine whether the efficacy of ivermectin and albendazole combination therapy has a statistically significant effect (p \< 0.05) on cure rates (CR) and egg reduction rates (ERR) compared to albendazole monotherapy. |
| Secondary | Determine statistically significant effect of combination therapy on patient's nutritional status based on z-scores | 3 months, 6 months, 9 months, 12 months after baseline enrolment | The investigators will determine if Ivermectin and Albendazole combination therapy has a statistically significant effect (p \< 0.05) on patients' nutritional status compared to Albendazole monotherapy. For that, the investigators will measure the height (in meters) and weight (in kilograms) of the children at baseline and in every follow-up period. Weight and height will be combined to report BMI in kg/m\^2. The investigators will then calculate the z-scores for height and weight according to age of the children using WHO Anthro software, v3.2.2, Switzerland. |
| Secondary | Correlate and compare changes in CR and ERR at different time points | 3 weeks, 3 months, 6 months, 9 months, 12 months after baseline enrolment | The investigators will correlate and compare changes in CR and ERR at different time points and patient outcomes according to the types STH infection. |
| Secondary | Determine statistically significant effect of combination therapy on patient's clinical condition (anaemia) based on haemoglobin count | At Baseline and 3 months after baseline enrolment | The investigators will determine if Ivermectin and Albendazole combination therapy has a statistically significant effect (p \< 0.05) on patients' clinical condition (anaemic status) compared to Albendazole monotherapy. For that, the investigators will conduct routine complete blood count (CBC) tests at baseline and 3-month follow-up periods and compare the mean of haemoglobin count and red cell indices (MCH, MCV, MCHC). Thus, evaluation of anemia will be used as an indicator of improvement of the clinical condition of the child. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers22
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07045493
GET https://conductscience.org/api/trials/v1/NCT07045493/papers?page=2