Trial · NCT02736968
Auranofin for Giardia Protozoa
NCT02736968, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2023-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Auranofin for Giardia Protozoa. Trials, record NCT02736968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02736968
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Auranofin for Giardia Protozoa
- NCT number
- NCT02736968
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 93 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Amoebic Dysentery, Giardiasis
- Interventions
- Auranofin, Placebo
- First posted
- 2016-04-13
- Last updated
- 2023-01-26
- Results first posted
- 2023-01-26
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia and Resolution of Diarrhea (Less Than 3 Loose Stools/24 Hours) | Day 5 | Diarrhea was assessed by self-report at each study visit. Resolution of diarrhea occurred when participants reported less than 3 loose stools in 24 hours. |
| Primary | Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia at Enrollment With Parasitological Response (no Detection of Cysts or Trophozoites on Microscopic Exam or Negative Antigen Test) | Day 5 | Participants provided stool samples on Day 5. Stool samples were assessed for parasitological response by detection of cysts or trophozoites via microscopic exam or a negative antigen test. |
| Secondary | Proportion of Participants With Negative Giardia Stool Antigens | Day 3 through Day 5 | Participants provided stool samples on Days 3 and 5. Stool samples were tested for Giardia using antigen detection EIA. Proportions are calculated as the number of participants with negative Giardia stool antigen tests divided by the number of participants with results available. |
| Secondary | Proportion of Symptomatic Participants With Positive Rapid EIA and Positive Antigen Detection EIA for Giardia and Trophozoites on Smear at Enrollment With Parasitological Response | Day 3 through Day 5 | Participants provided stool samples on Days 3 and 5. Stool samples were assessed for parasitological response by detection of trophozoites via microscopic exam. Proportions are calculated as the number of participants with parasitological response divided by the number of participants with results available. |
| Secondary | Proportion of Symptomatic Participants With Sustained Giardia Cure (no Detection of Trophozoites by Microscopic Exam) | Day 14 through Day 28 | Participants provided stool samples on Days 14 and 28. Stool samples were assessed for sustained Giardia cure by detection of trophozoites via microscopic exam. Proportion is calculated as the number of participants with sustained cure divided by the number of participants with results available. |
| Secondary | Giardia Trophozoite/Cyst Load by Quantitative Polymerase Chain Reaction (qPCR) in Stools of Symptomatic Participants | Day 3 through Day 5 | Participants provided stool samples on Days 3 and 5. The Giardia trophozoite/cyst load (parasites/uL) for each group was then assessed by Quantitative Polymerase Chain Reaction (qPCR). |
| Secondary | Time to Resolution of Diarrhea (Less Than 3 Loose Stools/24 Hours) | Day 1 through Day 28 | Diarrhea was assessed by self-report at each study visit. Resolution of diarrhea occurred when participants reported less than 3 loose stools in 24 hours. |
| Secondary | Proportion of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia at Enrollment With Parasitological Response (no Detection of Cysts or Trophozoites on Microscopic Exam or Negative Antigen Test) | Day 3 | Participants provided stool samples on Day3. Stool samples were assessed for parasitological response by detection of cysts or trophozoites via microscopic exam or a negative antigen test. Proportions are calculated as the number of participants with parasitological response divided by the number of participants with results available. |
| Secondary | Giardia Trophozoite/Cyst Load by Quantitative Polymerase Chain Reaction (qPCR) in Stools | Day 3 through Day 5 | Participants provided stool samples on Days 3 and 5. The Giardia trophozoite/cyst load (parasites/uL) for each group was then assessed by Quantitative Polymerase Chain Reaction (qPCR). |
| Secondary | Proportion of Asymptomatic Participants With Sustained Giardia Cure (no Detection of Trophozoites by Microscopic Exam) | Day 14 through Day 28 | Participants provided stool samples on Days 14 and 28. Stool samples were assessed for sustained Giardia cure by detection of cysts or trophozoites via microscopic exam or negative antigen detection. Proportions are calculated as the number of participants with sustained cure divided by the number of participants with results available. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia and Resolution of Diarrhea (Less Than 3 Loose Stools/24 Hours) | Day 5 | Modified Intention to Treat Population: All symptomatic participants who were randomized with available results, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia at Enrollment With Parasitological Response (no Detection of Cysts or Trophozoites on Microscopic Exam or Negative Antigen Test) | Day 5 | Modified Intention to Treat Population: All asymptomatic participants who were randomized, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants With Negative Giardia Stool Antigens | Day 3 through Day 5 | Modified Intention to Treat Population: All symptomatic participants who were randomized, dispensed at least one dose of study medication, had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Symptomatic Participants With Positive Rapid EIA and Positive Antigen Detection EIA for Giardia and Trophozoites on Smear at Enrollment With Parasitological Response | Day 3 through Day 5 | Modified Intention to Treat Population: All symptomatic participants who were randomized, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Symptomatic Participants With Sustained Giardia Cure (no Detection of Trophozoites by Microscopic Exam) | Day 14 through Day 28 | Modified Intention to Treat Population: All symptomatic participants who were randomized, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment. | proportion of participants | NUMBER |
| SECONDARY | Giardia Trophozoite/Cyst Load by Quantitative Polymerase Chain Reaction (qPCR) in Stools of Symptomatic Participants | Day 3 through Day 5 | Modified Intention to Treat Population: All symptomatic participants who were randomized, dispensed at least one dose of study medication, had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment, with available results. | log parasite load/uL | MEAN |
| SECONDARY | Time to Resolution of Diarrhea (Less Than 3 Loose Stools/24 Hours) | Day 1 through Day 28 | Modified Intention to Treat Population: All symptomatic participants who were randomized, dispensed at least one dose of study medication, had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment, with available results. | days | NUMBER |
| SECONDARY | Proportion of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia at Enrollment With Parasitological Response (no Detection of Cysts or Trophozoites on Microscopic Exam or Negative Antigen Test) | Day 3 | Modified Intention to Treat Population: All participants who were randomized, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment. | proportion with parasitological response | NUMBER |
| SECONDARY | Giardia Trophozoite/Cyst Load by Quantitative Polymerase Chain Reaction (qPCR) in Stools | Day 3 through Day 5 | Modified Intention to Treat Population: All asymptomatic participants who were randomized, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment. | log parasite load/uL | MEAN |
| SECONDARY | Proportion of Asymptomatic Participants With Sustained Giardia Cure (no Detection of Trophozoites by Microscopic Exam) | Day 14 through Day 28 | Modified Intention to Treat Population: All asymptomatic participants who were randomized, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment. | proportion of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia and Resolution of Diarrhea (Less Than 3 Loose Stools/24 Hours) | Symptomatic Giardia- Auranofin | 28 | Participants | ||
| Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia and Resolution of Diarrhea (Less Than 3 Loose Stools/24 Hours) | Symptomatic Giardia- Placebo | 28 | Participants | ||
Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia at Enrollment With Parasitological Response (no Detection of Cysts or Trophozoites on Microscopic Exam or Negative Antigen Test) | Asymptomatic Giardia- Auranofin | 6 | Participants | ||
Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia at Enrollment With Parasitological Response (no Detection of Cysts or Trophozoites on Microscopic Exam or Negative Antigen Test) | Asymptomatic Giardia- Placebo | 6 | Participants | ||
| Proportion of Participants With Negative Giardia Stool Antigens | Symptomatic Giardia- Auranofin | Day 3 | 0.45 | 95% Confidence Interval 0.28 to 0.62 | proportion of participants |
| Proportion of Participants With Negative Giardia Stool Antigens | Symptomatic Giardia- Placebo | Day 3 | 0.38 | 95% Confidence Interval 0.23 to 0.56 | proportion of participants |
| Proportion of Participants With Negative Giardia Stool Antigens | Symptomatic Giardia- Auranofin | Day 5 | 0.55 | 95% Confidence Interval 0.38 to 0.72 | proportion of participants |
| Proportion of Participants With Negative Giardia Stool Antigens | Symptomatic Giardia- Placebo | Day 5 | 0.34 | 95% Confidence Interval 0.20 to 0.53 | proportion of participants |
| Proportion of Symptomatic Participants With Positive Rapid EIA and Positive Antigen Detection EIA for Giardia and Trophozoites on Smear at Enrollment With Parasitological Response | Symptomatic Giardia- Auranofin | Day 3 | 0.97 | 95% Confidence Interval 0.81 to 1.00 | proportion of participants |
| Proportion of Symptomatic Participants With Positive Rapid EIA and Positive Antigen Detection EIA for Giardia and Trophozoites on Smear at Enrollment With Parasitological Response | Symptomatic Giardia- Placebo | Day 3 | 0.93 | 95% Confidence Interval 0.77 to 0.99 | proportion of participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Asymptomatic E. Histolytica- Auranofin | 0 | |
| Overall Study | STARTED | Asymptomatic E. Histolytica- Placebo | 1 | |
| Overall Study | STARTED | Asymptomatic Giardia- Auranofin | 17 | |
| Overall Study | STARTED | Asymptomatic Giardia- Placebo | 16 | |
| Overall Study | STARTED | Symptomatic E. Histolytica- Auranofin | 0 | |
| Overall Study | STARTED | Symptomatic E. Histolytica- Placebo | 0 | |
| Overall Study | STARTED | Symptomatic Giardia- Auranofin | 30 | |
| Overall Study | STARTED | Symptomatic Giardia- Placebo | 29 | |
| Overall Study | COMPLETED | Asymptomatic E. Histolytica- Auranofin | 0 | |
| Overall Study | COMPLETED | Asymptomatic E. Histolytica- Placebo | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events90
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 | Vertigo | Ear and labyrinth disorders | Asymptomatic E. Histolytica- Placebo | 0 | 1 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Asymptomatic Giardia- Auranofin | 1 | 17 | 2 |
| other | Vertigo | Ear and labyrinth disorders | Asymptomatic Giardia- Placebo | 1 | 16 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Symptomatic Giardia- Auranofin | 0 | 30 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Symptomatic Giardia- Placebo | 2 | 29 | 2 |
| other | Abdominal Pain | Gastrointestinal disorders | Asymptomatic E. Histolytica- Placebo | 0 | 1 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Asymptomatic Giardia- Auranofin | 1 | 17 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Asymptomatic Giardia- Placebo | 0 | 16 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Symptomatic Giardia- Auranofin | 0 | 30 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Symptomatic Giardia- Placebo | 0 | 29 | 0 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Asymptomatic E. Histolytica- Placebo | 0 | 1 |
| Total, all-cause mortality | Asymptomatic Giardia- Auranofin | 0 | 17 |
| Total, all-cause mortality | Asymptomatic Giardia- Placebo | 0 | 16 |
| Total, all-cause mortality | Symptomatic Giardia- Auranofin | 0 | 30 |
| Total, all-cause mortality | Symptomatic Giardia- Placebo | 0 | 29 |
| Total, other adverse events | Asymptomatic E. Histolytica- Placebo | 0 | 1 |
| Total, other adverse events | Asymptomatic Giardia- Auranofin | 9 | 17 |
| Total, other adverse events | Asymptomatic Giardia- Placebo | 7 | 16 |
| Total, other adverse events | Symptomatic Giardia- Auranofin | 0 | 30 |
| Total, other adverse events | Symptomatic Giardia- Placebo | 2 | 29 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Asymptomatic Giardia- Auranofin vs Asymptomatic Giardia- Placebo: Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia at Enrollment With Parasitological Response (no Detection of Cysts or Trophozoites on Microscopic Exam or Negative Antigen Test) | Trial comparisons |
Symptomatic Giardia- Auranofin vs Symptomatic Giardia- Placebo: Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia and Resolution of Diarrhea (Less Than 3 Loose Stools/24 Hours) | Trial comparisons |
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/NCT02736968
GET https://conductscience.org/api/trials/v1/NCT02736968/results?page=2