Trial · NCT07543458
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression to severe dengue/critical dengue | between randomization to hospital discharge (average of 5 days) | In the trial, baseline severity of dengue will be assessed at the start of study participation. Participants will be defined in accordance with our case definitions as having moderate, severe or critical dengue, based on clinical signs and symptoms, laboratory parameters, and if they have evidence of organ failure with or without need for organ support. At hospital discharge or following death, we will capture if the participant had evidence of at least one of: * Progression to Severe dengue, in a participant with moderate dengue at enrolment, * Progression to Critical dengue, in a participant with moderate or severe dengue at enrolment. |
| Primary | All-cause mortality within 30 days | Day 30 | All-cause mortality in any participant. Assessed as dead or alive |
| Secondary | Length of hospital stay | At hospital discharge (average of 5 days) | Number of days from hospital admission to discharge |
| Secondary | Lowest recorded platelet count | Between randomisation and hospital discharge (average of 5 days) | Lowest recorded platelet count between randomisation and hospital discharge |
| Secondary | Acute kidney injury | Between randomisation and hospital discharge (average of 5 days) | Serum creatinine \> 3.5 mg/dL or more than double baseline |
| Secondary | Liver involvement | Between randomisation and hospital discharge (average of 5 days) | Highest recorded ALT or AST |
| Secondary | Change in ALT/AST | at randomisation, day 2 (if feasible) and day 4 or hospital discharge (average on day 5) if sooner | N-acetylcysteine treatment comparison only. Fold change in ALT or AST |
| Secondary | Highest bilirubin | Between randomisation and hospital discharge (average of 5 days) | N-acetylcysteine treatment comparison only. Highest recorded bilirubin |
| Secondary | Highest INR | Between randomisation and hospital discharge (average of 5 days) | N-acetylcysteine treatment comparison only. Highest recorded INR |
| Secondary | Safety reporting: Suspected Severe Adverse Reactions | During hospital stay (average of 5 days) and at day 30 follow up | Suspected serious adverse reactions (SSARs) excluding primary outcomes |
| Secondary | Quality of live assessment using EQ-5D-5L value index | at day 30 follow up | The EQ-5D-5L (EuroQoL \[European Quality of Life\] 5-Dimension 5-Level) is a standardized measure of health-related quality of life assessing five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is self-reported by the respondent and rated on five levels of severity, ranging from "no problems" (level 1) to "extreme problems/unable" (level 5). Responses across the five domains define a health state, which is converted into a single index (utility) score using population-based value sets. This index score typically ranges from values below 0 (health states considered worse than death) to 1 (perfect health). |
| Secondary | Quality of live assessment using EQ-Visual Analogue Scale (VAS) | at day 30 follow up | This is a self-rated measure of overall health. Respondent indicate their current health status on a vertical scale from 0 to 100. A score of 0 represents "the worst health you can imagine" and 100 represents "the best health you can imagine". This measure captures the respondent's subjective assessment of their overall health on the day of evaluation. When this assessment done remotely by telephone, the rating is approximated verbally by the respondent using the 0 to 100 numeric scale. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT07543458/registered