Empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia: a multicenter, open-label randomized controlled clinical trial

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 624

Inclusion Criteria

1.Age 28 days to 365 days of age
2.Pneumonia defined as chest indrawing or fast breathing for age, for infants 28 to 60 days of age =60 breaths per minute and for infants 61 to 365 days of age, =50 breaths per minute.
3.Current hospitalization due to pneumonia with criteria for parenteral antibiotics (1 or more criteria)
a)Chest indrawing with HIV infection
b)No improvement with oral treatment.
c)One or more danger signs according to WHO
-Central cyanosis or saturation of O2 <90%
-Severe respiratory distress, e.g. grunting or very severe chest indrawing
-Signs of pneumonia with a general danger sign:
-Unable to drink or breastfeed
-Persisting vomiting
-Convulsions in the last 24 hours
-Lethargic or unconscious
-Stridor while calm
-Severe malnutrition
4.HIV-confirmed infection (with at least one molecular method: DNA PCR or RNA PCR/viral load).
5.Informed consent obtained

Exclusion Criteria

1.Clinical TB (pulmonary or extrapulmonary) diagnosis, defined as the necessity of TB-T prescribed by a physician, at the moment of randomization
2.Known bacteriologically confirmed TB case (at least one biological specimen positive by culture or Xpert MTB/RIF) at the moment of randomization
3.Patient previously treated for TB or currently on treatment for TB
4.Documented evidence of close TB exposure (household contact of a patient with documented TB during the lifetime of the child, or currently receiving TB-T)
5.Pure wheezers defined as a clear clinical improvement after a bronchodilator test (give a challenge of rapid-acting inhaled bronchodilator for up to three times 15-20 minutes apart. Count the breaths and look for chest indrawing again, and then re-classify)
6.Active malignancies
7.Systemic immunosuppressive medications. Steroids will be considered to be immunosuppressing only if >2 mg/kg of prednisone or equivalent during >15 days
8.Evidence of condition other than HIV and pneumonia which precludes, to the judgment of the clinical researcher, enrollment in this trial due to risk for the patient. In case of doubt, the Trial Management Team will be contacted to assess eligibility
9.Less than 2.5 kg of weight
10.Hb <6 g/dL in the screening blood test or in a test done in the last 48 hours. Transfusion is permitted to achieve >6 g/dL if the patient’s state allows it. In case a transfusion is administered, the patient can be enrolled
11.Neutropenia <500 /mm3 in the screening blood test or in a test done in the last 48 hours. Repeating the test is allowed to check eligibility

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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