Trial · NCT01377480
A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)
NCT01377480, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2015-08-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267). Trials, record NCT01377480. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01377480
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)
- NCT number
- NCT01377480
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 120 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Chagas Disease
- Interventions
- Posaconazole, Placebo for posaconazole, Benznidazole
- First posted
- 2011-06-21
- Last updated
- 2018-08-27
- Results first posted
- 2015-08-10
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction | Day 180 | Blood samples were collected for qualitative polymerase chain reaction (PCR) assay for Trypanosoma cruzi deoxyribonucleic acid (DNA). Successful response was defined as a negative qualitative PCR value at the Day 180 follow up visit. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction | Day 180 | The Full Analysis Population included all randomized subjects who received at least one dose of study drug. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction | Posaconazole | 15.6 | 95% Confidence Interval 6.9 to 31.8 | Percentage of participants | |
| Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction | Placebo | 10.0 | 95% Confidence Interval 3.5 to 25.6 | Percentage of participants | |
| Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction | Posaconazole + Benznidazole | 82.1 | 95% Confidence Interval 64.4 to 92.1 | Percentage of participants | |
| Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction | Benznidazole + Placebo | 86.7 | 95% Confidence Interval 70.3 to 94.7 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Posaconazole | 32 | |
| Overall Study | STARTED | Placebo | 30 | |
| Overall Study | STARTED | Posaconazole + Benznidazole | 28 | |
| Overall Study | STARTED | Benznidazole + Placebo | 30 | |
| Overall Study | COMPLETED | Posaconazole | 32 | |
| Overall Study | COMPLETED | Placebo | 29 | |
| Overall Study | COMPLETED | Posaconazole + Benznidazole | 18 | |
| Overall Study | COMPLETED | Benznidazole + Placebo | 19 | |
| Overall Study | NOT COMPLETED | Posaconazole | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events116
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 upper | Gastrointestinal disorders | Posaconazole | 0 | 32 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 1 | 30 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Posaconazole + Benznidazole | 3 | 28 | 3 |
| other | Abdominal pain upper | Gastrointestinal disorders | Benznidazole + Placebo | 2 | 30 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Posaconazole | 0 | 32 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 30 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Posaconazole + Benznidazole | 0 | 28 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Benznidazole + Placebo | 0 | 30 | 0 |
| other | Gastritis | Gastrointestinal disorders | Posaconazole | 3 | 32 | 3 |
| other | Gastritis | Gastrointestinal disorders | Placebo | 0 | 30 | 0 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Posaconazole | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Posaconazole + Benznidazole | ||
| Total, all-cause mortality | Benznidazole + Placebo | ||
| Total, other adverse events | Posaconazole | 12 | 32 |
| Total, other adverse events | Placebo | 8 | 30 |
| Total, other adverse events | Posaconazole + Benznidazole | 18 | 28 |
| Total, other adverse events | Benznidazole + Placebo | 21 | 30 |
| Total, serious adverse events | Posaconazole | 1 | 32 |
| Total, serious adverse events | Placebo | 1 | 30 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28231946 | RESULT |
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.
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/NCT01377480
GET https://conductscience.org/api/trials/v1/NCT01377480/events?page=2