Trial · NCT03915366
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mortality | 1 year | The primary endpoint of the study is all-cause mortality, focusing on the short term (up to 15-days) and long-term (up to 1-year) mortality. Mortality will be calculated using all-cause mortality after the admission over all the trial time. |
| Secondary | Days with oxygen therapy | 60 days | 1\. Duration of oxygen requirements (in days, from the first requirement until definitive withdrawal, being day 1 the first day of oxygen requirement). |
| Secondary | Days of hospitalization | 1 year | 2\. Cumulative days of hospitalization from discharge to day +365 after enrollment |
| Secondary | Serious Adverse Events | 1 year | Serious Adverse Events (SAEs), this is, grade 3 and 4 AEs. |
| Secondary | Adverse Reactions | 1 year | Adverse Reactions (AR) |
| Secondary | Notable Adverse Events | 1 year | Adverse events (AEs) requiring stop of investigational medical product (IMP), all AEs relevant for risk/benefit ratio, including infections, liver toxicity, neurological and optic toxicity, renal, hematological and any AE grade 1, 2, 3 or 4 that the investigator estimates to be relevant |
| Secondary | Immune-reconstitution inflammatory syndrome | 6 months | Incidence of TB-related immune-reconstitution inflammatory syndrome (IRIS) |
| Secondary | Baseline cytomegalovirus prevalence | 30 days | Baseline prevalence of CMV infection and CMV-attributable pneumonia (based in a CMV viral load threshold) in recruited HIV-infected infants with severe pneumonia |
| Secondary | Baseline tuberculosis prevalence | 60 days | Baseline prevalence of microbiological confirmed and unconfirmed TB (according to Graham criteria, Updated Clinical Case Definitions for Classification of Intrathoracic Tuberculosis in Children 2015) in recruited HIV-infected patients with severe pneumonia |
| Secondary | Tuberculosis incidence | 1 year | New confirmed and unconfirmed TB cases according to Graham criteria during 1-year of follow-up among patients without TB-T |
| Secondary | Deaths attributable to tuberculosis | 1 year | Proportion of confirmed and unconfirmed TB, according to Graham criteria, in died children |
| Secondary | CMV prevalence in died participants | 1 year | Proportion of CMV infection in died children |
| Secondary | CMV Molecular response to treatment | 1 year | Reduction of quantitative CMV viral load in blood and saliva in infants treated with valganciclovir from enrollment to day +15 |
| Secondary | TB-lipoarabinomannan (LAM) sensitivity and specificity | 1 year | To assess the diagnostic accuracy (sensitivity and specificity) of TB-LAM for the diagnosis of confirmed TB (reference: positive Xpert Mycobacterium tuberculosis (MTB)/RIF Ultra in feces and/or NPA) |
| Secondary | Quality-adjusted life expectancy | 1 year | Economic evaluation for quality-adjusted life expectancy |
| Secondary | Per-patient cost | 1 year | Economic evaluation of the treatments (per-patient cost) |
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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