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| ID | Type | Description | Link |
|---|---|---|---|
| MK-5592-055 | Other Identifier | Merck Protocol Number |
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This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg twice daily improves therapeutic response compared to placebo in participants with a diagnosis of asymptomatic chronic Chagas disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posaconazole | Experimental | Posaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days |
|
| Placebo | Placebo Comparator | Posaconazole placebo (10 mL) oral suspension twice daily for 60 days |
|
| Posaconazole + Benznidazole | Experimental | Posaconazole 400 mg (10 mL) oral suspension twice daily for 60 days and benznidazole (BNZ) 100 mg oral tablet twice daily (200-mg daily dose) for 60 days |
|
| Benznidazole + Placebo | Active Comparator | Posaconazole placebo (10 mL) oral suspension twice daily for 60 days and benznidazole 100 mg oral tablet twice daily (200-mg daily dose) for 60 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posaconazole | Drug | POS 40 mg/mL oral suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction | 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. | Day 180 |
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Inclusion Criteria:
- Must have a positive serology result for Trypanosoma cruzi on any 2 of 3 of the following tests: indirect immunofluorescence, indirect hemagglutination, or enzyme-linked immunoabsorbent assay (ELISA)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28231946 | Result | Morillo CA, Waskin H, Sosa-Estani S, Del Carmen Bangher M, Cuneo C, Milesi R, Mallagray M, Apt W, Beloscar J, Gascon J, Molina I, Echeverria LE, Colombo H, Perez-Molina JA, Wyss F, Meeks B, Bonilla LR, Gao P, Wei B, McCarthy M, Yusuf S; STOP-CHAGAS Investigators. Benznidazole and Posaconazole in Eliminating Parasites in Asymptomatic T. Cruzi Carriers: The STOP-CHAGAS Trial. J Am Coll Cardiol. 2017 Feb 28;69(8):939-947. doi: 10.1016/j.jacc.2016.12.023. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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A total of 393 participants were screened, 123 were eligible for enrollment, and 120 were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Posaconazole | POS 400 mg (10 mL) oral suspension twice daily for 60 days |
| FG001 | Placebo | POS placebo (10 mL) oral suspension twice daily for 60 days |
| FG002 | Posaconazole + Benznidazole | POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days |
| FG003 | Benznidazole + Placebo | BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Posaconazole | POS 400 mg (10 mL) oral suspension twice daily for 60 days |
| BG001 | Placebo | POS placebo (10 mL) oral suspension twice daily for 60 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction | 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. | The Full Analysis Population included all randomized subjects who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 180 |
|
All adverse events: up to Day 90 (30 days post treatment); procedure-related serious adverse events: up to Day 360 (300 days post treatment)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Posaconazole | POS 400 mg (10 mL) oral suspension twice daily for 60 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme, Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D014355 | Chagas Disease |
| ID | Term |
|---|---|
| D014352 | Trypanosomiasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| C101425 | posaconazole |
| C009999 | benzonidazole |
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| Placebo for posaconazole | Drug | Placebo oral suspension |
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| Benznidazole | Drug | BNZ 100 mg oral tablet |
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| Evidence of drug-induced hepatotoxicity |
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| Withdrawal by Subject |
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| Serious adverse event |
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| Other |
|
| BG002 | Posaconazole + Benznidazole | POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days |
| BG003 | Benznidazole + Placebo | BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
POS placebo (10 mL) oral suspension twice daily for 60 days
| OG002 | Posaconazole + Benznidazole | POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days |
| OG003 | Benznidazole + Placebo | BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days |
|
|
| 1 |
| 32 |
| 12 |
| 32 |
| EG001 | Placebo | POS placebo (10 mL) oral suspension twice daily for 60 days | 1 | 30 | 8 | 30 |
| EG002 | Posaconazole + Benznidazole | POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days | 2 | 28 | 18 | 28 |
| EG003 | Benznidazole + Placebo | BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days | 3 | 30 | 21 | 30 |
| Hepatitis | Hepatobiliary disorders | MedDRA version 14.0 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA version 14.0 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA version 14.0 | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA version 14.0 | Systematic Assessment |
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| Photodermatosis | Skin and subcutaneous tissue disorders | MedDRA version 14.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 14.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA version 14.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 14.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA version 14.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
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| Transaminase increased | Investigations | MedDRA version 14.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 14.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 14.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 14.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA version 14.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA version 14.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 14.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 14.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 14.0 | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA version 14.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 14.0 | Systematic Assessment |
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The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts with regard to proprietary information, accuracy, and fair-balance and compliance.
| D007239 |
| Infections |
| D000079426 | Vector Borne Diseases |