Trial · NCT04010539
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Microbiological intent-to-treat (Micro-ITT) population included all participants randomly assigned to study treatment who received at least 1 dose of study treatment and have confirmed NG isolated that is ceftriaxone-susceptible (based on CLSI breakpoints) from baseline culture of their urogenital specimen. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit | Baseline (Day 1) and TOC visit (Day 4 to 8) | Micro-ITT Rectal population included all participants who met the definition of the Micro-ITT Population and have confirmed NG isolated that is ceftriaxone susceptible from baseline culture of their rectal specimen. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit | Baseline (Day 1) and TOC visit (Day 4 to 8) | Micro-ITT Pharyngeal population included all participants who met the definition of the Micro-ITT Population and have confirmed NG isolated that is ceftriaxone susceptible from baseline culture of their pharyngeal specimen. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs) | Up to 21 days | Safety population included all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Giga cells per liter (10^9 cells/L) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Grams per liter (g/L) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Percentage | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Trillion cells per liter (10^12 cells/L) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Picograms (pg) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Femtoliters (fL) | MEAN |
| SECONDARY | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Micromoles per liter (umol/L) | MEAN |
| SECONDARY | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Grams per liter (g/L) | MEAN |
| SECONDARY | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | International units per Liter (IU/L) | MEAN |
| SECONDARY | Number of Participants With Urinalysis Dipstick Results | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Absolute Values in Specific Gravity of Urine | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Ratio | MEAN |
| SECONDARY | Absolute Values in Potential of Hydrogen (pH) of Urine | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | pH | MEAN |
| SECONDARY | Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Vital Sign: Pulse Rate | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Beats per minute | MEAN |
| SECONDARY | Change From Baseline in Vital Sign: Temperature | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Celsius (C) | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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