Clinical Trial


Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia


Brief description

This trial will evaluate whether empirical treatment against cytomegalovirus and tuberculosis improves survival of HIV-infected infants with severe pneumonia.

Detailed Description

Pneumonia is the main cause of death in Human Immunodeficiency Virus (HIV)-infected children. A significant number of undiagnosed or poorly treated HIV-infected children present to health services with severe pneumonia. World Health Organization (WHO) guidelines to treat severe pneumonia in HIV-infected infants include empirical treatment against common bacteria plus Pneumocystis jirovecii. Although this approach has contributed to reducing overall case fatality rates, mortality in this particularly vulnerable group remains unacceptably high. Autopsy studies in Africa have shown that cytomegalovirus (CMV) infection and tuberculosis (TB) are important underdiagnosed and undertreated causes of deaths. Our objective is to evaluate whether empirical treatment against cytomegalovirus and tuberculosis improves survival of HIV-infected infants with severe pneumonia. A randomized factorial clinical trial will be conducted in six sub-Saharan African countries to evaluate the safety and efficacy of empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants aged 28 days to 365 days admitted to hospital with severe pneumonia. The primary outcome is mortality. All HIV-infected infants will receive standard of care (SoC) pneumonia treatment, including antibiotics, cotrimoxazole, and prednisolone. A group of patients will receive SoC, another group will receive valganciclovir plus SoC, another group will receive tuberculosis treatment plus SoC, and another group will receive valganciclovir, tuberculosis treatment, and SoC.

Keywords

  •   HIV/AIDS
  •   Tuberculosis
  •   Cytomegalovirus Infections
  •   Pneumonia

Sponsored By

Hospital Universitario 12 de Octubre

Unique Study ID

NCT03915366

Investigators and Research Sites Near You - Found( 3 )

No Investigator Listed

French Africa Pediatric Oncology Group
Abidjan, Côte D'Ivoire
Distance from Current Trial is 0 miles

No Investigator Listed

French Africa Pediatric Oncology Group
Abidjan, Côte D'Ivoire
Distance from Current Trial is 0 miles

No Investigator Listed

ANRS, Emerging Infectious Diseases
Abidjan, Côte D'Ivoire
Distance from Current Trial is 0 miles
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