Trial · NCT06188715

Efficacy and Safety of Moxidectin-Albendazole Co-administration in SAC

NCT06188715, Phase 3, Completed, Jennifer Keiser; results first posted 2025-09-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Moxidectin-Albendazole Co-administration in SAC. Trials, record NCT06188715. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06188715

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Moxidectin-Albendazole Co-administration in SAC
NCT number: NCT06188715
Status: Completed
Phases: Phase 3
Enrollment: 224 participants, actual
Lead sponsor: Jennifer Keiser
Conditions: Trichuriasis, Ascariasis, Hookworm Infections
Interventions: Moxidectin 2 mg Oral Tablet, Albendazole 400 mg Oral Tablet, Placebo Moxidectin, Placebo Albendazole
First posted: 2024-01-03
Last updated: 2025-09-19
Results first posted: 2025-09-19

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cure Rate (CR) Against T. Trichiura	14-21 days post-treatment	The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Secondary	Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR)	14-21 days post-treatment	Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Secondary	Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR)	14-21 days post-treatment	Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Secondary	Cure Rate (CR) Against A. Lumbricoides	14-21 days post-treatment	The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Secondary	Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR)	14-21 days post-treatment	Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Secondary	Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR)	14-21 days post-treatment	Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Secondary	Cure Rate (CR) Against Hookworm	14-21 days post-treatment	The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Secondary	Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR)	14-21 days post-treatment	Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Secondary	Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR)	14-21 days post-treatment	Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Secondary	Number of Participants Reporting Adverse Events (AEs)	3 hours, 24 hours and 14-21 days post-treatment	Participants will be monitored at the site for 3 hours following treatment for any acute AEs and reassessment will be done at 24h post-treatment. In addition, participants will be interviewed 3 and 24 hours after treatment and retrospectively at days 14-21 about the occurrence of AEs.

1 to 10 of 11Source ClinicalTrials.gov

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Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cure Rate (CR) Against T. Trichiura	14-21 days post-treatment	Available case population.	percentage of participants cured (%)	NUMBER
SECONDARY	Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR)	14-21 days post-treatment	Available case population.	percent change in egg counts (%)	GEOMETRIC_MEAN
SECONDARY	Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR)	14-21 days post-treatment	Available case population.	percent change in egg counts (%)	MEAN
SECONDARY	Cure Rate (CR) Against A. Lumbricoides	14-21 days post-treatment	Subset of participants co-infected with A. lumbricoides at baseline and providing follow-up data.	percentage of participants cured (%)	NUMBER
SECONDARY	Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR)	14-21 days post-treatment	Subset of participants co-infected with A. lumbricoides at baseline and providing follow-up data.	percent change in egg counts (%)	GEOMETRIC_MEAN
SECONDARY	Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR)	14-21 days post-treatment	Subset of participants co-infected with A. lumbricoides at baseline and providing follow-up data.	percent change in egg counts (%)	MEAN
SECONDARY	Cure Rate (CR) Against Hookworm	14-21 days post-treatment	Subset of participants co-infected with hookworm at baseline and providing follow-up data.	percentage of participants cured (%)	NUMBER
SECONDARY	Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR)	14-21 days post-treatment	Subset of participants co-infected with hookworm at baseline and providing follow-up data.	percent change in egg counts (%)	GEOMETRIC_MEAN
SECONDARY	Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR)	14-21 days post-treatment	Subset of participants co-infected with hookworm at baseline and providing follow-up data.	percent change in egg counts (%)	MEAN
SECONDARY	Number of Participants Reporting Adverse Events (AEs)	3 hours, 24 hours and 14-21 days post-treatment	All participants receiving treatment.	participants	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

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Results by group81

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Cure Rate (CR) Against T. Trichiura	Arm A: Moxidectin 4/8 mg & Albendazole	69.4	95% Confidence Interval 59.9 to 77.8	percentage of participants cured (%)
Cure Rate (CR) Against T. Trichiura	Arm B: Albendazole	16.2	95% Confidence Interval 8.4 to 27.1	percentage of participants cured (%)
Cure Rate (CR) Against T. Trichiura	Arm C: Placebo	11.8	95% Confidence Interval 3.3 to 27.5	percentage of participants cured (%)
Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR)	Arm A: Moxidectin 4/8 mg & Albendazole	99.1	95% Confidence Interval 98.6 to 99.5	percent change in egg counts (%)
Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR)	Arm B: Albendazole	64.4	95% Confidence Interval 42.9 to 78.3	percent change in egg counts (%)
Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR)	Arm C: Placebo	14.6	95% Confidence Interval -28.3 to 46.5	percent change in egg counts (%)
Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR)	Arm A: Moxidectin 4/8 mg & Albendazole	91.1	95% Confidence Interval 82.5 to 96.0	percent change in egg counts (%)
Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR)	Arm B: Albendazole	-12.9	95% Confidence Interval -121.5 to 51.5	percent change in egg counts (%)
Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR)	Arm C: Placebo	-123.9	95% Confidence Interval -196.9 to -11.0	percent change in egg counts (%)
Cure Rate (CR) Against A. Lumbricoides	Arm A: Moxidectin 4/8 mg & Albendazole	97.2	95% Confidence Interval 85.5 to 99.9	percentage of participants cured (%)

1 to 10 of 81Source ClinicalTrials.gov

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Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A: Moxidectin 4/8 mg & Albendazole	114
Overall Study	STARTED	Arm B: Albendazole	74
Overall Study	STARTED	Arm C: Placebo	36
Overall Study	COMPLETED	Arm A: Moxidectin 4/8 mg & Albendazole	111
Overall Study	COMPLETED	Arm B: Albendazole	68
Overall Study	COMPLETED	Arm C: Placebo	34
Overall Study	NOT COMPLETED	Arm A: Moxidectin 4/8 mg & Albendazole	3
Overall Study	NOT COMPLETED	Arm B: Albendazole	6
Overall Study	NOT COMPLETED	Arm C: Placebo	2

Source ClinicalTrials.gov

Adverse events21

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain	Gastrointestinal disorders	Arm A: Moxidectin 4/8 mg & Albendazole	5	114	5
other	Abdominal pain	Gastrointestinal disorders	Arm B: Albendazole	2	74	2
other	Abdominal pain	Gastrointestinal disorders	Arm C: Placebo	1	36	2
other	Diarrhoea	Gastrointestinal disorders	Arm A: Moxidectin 4/8 mg & Albendazole	0	114	0
other	Diarrhoea	Gastrointestinal disorders	Arm B: Albendazole	0	74	0
other	Diarrhoea	Gastrointestinal disorders	Arm C: Placebo	1	36	1
other	Nausea	Gastrointestinal disorders	Arm A: Moxidectin 4/8 mg & Albendazole	0	114	0
other	Nausea	Gastrointestinal disorders	Arm B: Albendazole	0	74	0
other	Nausea	Gastrointestinal disorders	Arm C: Placebo	1	36	1
other	Vomiting	Gastrointestinal disorders	Arm A: Moxidectin 4/8 mg & Albendazole	0	114	0

1 to 10 of 21Source ClinicalTrials.gov

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Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A: Moxidectin 4/8 mg & Albendazole	0	114
Total, all-cause mortality	Arm B: Albendazole	0	74
Total, all-cause mortality	Arm C: Placebo	0	36
Total, other adverse events	Arm A: Moxidectin 4/8 mg & Albendazole	10	114
Total, other adverse events	Arm B: Albendazole	3	74
Total, other adverse events	Arm C: Placebo	3	36
Total, serious adverse events	Arm A: Moxidectin 4/8 mg & Albendazole	0	114
Total, serious adverse events	Arm B: Albendazole	0	74
Total, serious adverse events	Arm C: Placebo	0	36

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40675166	DERIVED

Source PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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Read this trial from software.

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