Trial · NCT03915366
Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia
NCT03915366, Phase 2, Phase 3, Completed, Hospital Universitario 12 de Octubre
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia. Trials, record NCT03915366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03915366
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia
- NCT number
- NCT03915366
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 563 participants, actual
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Conditions
- Pneumonia, HIV/AIDS, Tuberculosis, Cytomegalovirus Infections
- Interventions
- Valganciclovir Oral Solution [Valcyte], Tuberculostatic Agents
- First posted
- 2019-04-16
- Last updated
- 2025-09-19
- Other registries' IDs
- eudract:2019-001749-42
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT03915366
GET https://conductscience.org/api/trials/v1/NCT03915366/registered