Does treating cytomegalovirus and tuberculosis very early (even without being sure if the child has these infections) in addition to the usual treatment for pneumonia save HIV-positive children’s movement and reasoning?

Not Applicable

• Conditions: eurocognitive function among HIV-infected children hospitalized with severe pneumonia; Nervous System Diseases

• Registration Number: ISRCTN80374799
• Lead Sponsor: Makerere University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-17
• Last Update Posted: 9 September 2024
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Cohort of HIV positive children with severe pneumonia:
1. Aged between 28 and 365 days
2. Participating in the EMPIRICAL trial
3. Current hospitalization due to pneumonia with criteria for parenteral antibiotics (=1 World Health Organization criteria)
4. Pneumonia, defined as chest indrawing or fast breathing for age (for infants aged 28 to 60 days, =60 breaths per minute; for infants aged 61 to 365 days, =50 breaths per minute)
5. HIV-confirmed infection (with at least one molecular method: DNA PCR or RNA PCR/viral load)
6. Informed consent obtained from caregivers

Cohort of HIV negative children with severe pneumonia:
1. Aged between 28 and 365 days
2. Current hospitalization due to pneumonia with criteria for parenteral antibiotics (=1 World Health Organization criteria)
3. Pneumonia, defined as chest indrawing or fast breathing for age (for infants aged 28 to 60 days, =60 breaths per minute; for infants aged 61 to 365 days, =50 breaths per minute)
4. Informed consent obtained from caregivers

Cohort of HIV positive children without pneumonia:
1. Aged between 28 and 365 days
2. HIV-confirmed infection (with at least one molecular method: DNA PCR or RNA PCR/viral load)
3. Informed consent obtained from caregivers

Exclusion Criteria

1. Clinical TB (pulmonary or extrapulmonary) diagnosis. Defined as the necessity of TB treatment prescribed by a physician, known bacteriologically confirmed TB case (at least one biological specimen positive by culture or Xpert MTB/RIF) at the moment of randomization, previously treated for TB or currently on treatment for TB, or documented evidence of close TB exposure.
2. Pure wheezers. Defined as a clear clinical improvement after a bronchodilator test.
3. Active malignancies, systemic immunosuppressive medications, or evidence of condition other than HIV and pneumonia
4. Weighing <2.5 kg
5. Hemoglobin less than <6 g/dl in the screening blood test or in a test done in the last 48 h
6. Neutropenia <500 /mm³ in the screening blood test or in a test done in the last 48 h

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development measured in participants the intervention group (empirical treatment for CMV, TB, or both) and SoC alone using mean scaled scores on the Bayley scale of infant development at discharge, 1 year post-randomization, and at 2 years of age

Secondary Outcome Measures

Name	Time	Method
1. Development measured in participants the intervention group (empirical treatment for CMV, TB, or both), SoC alone, and a matched cohort of HIV-positive infants without pneumonia using mean scaled scores on the Bayley scale of infant development at discharge, 1-year post-randomization, and at 2 years of age<br>2. Development measured in participants the intervention group (empirical treatment for CMV, TB, or both), SoC alone, and a cohort of HIV negative infants with severe pneumonia using mean scaled scores on the Bayley scale of infant development at discharge, 1 year post-randomization, and at 2 years of age