INTERVENTIONS |
Intervention type
|
Intervention name
|
Dose
|
Duration
|
Intervention description
|
Group size
|
Nature of control
|
Control Group |
Standard of Care |
Ceftriaxone 80 mg/k/day or Ampicillin plus Gentamicin ampicillin 50 mg/kg, or benzylpenicillin 50,000 unit/kg im/iv every six hours plus Gentamicin 7.5 mg/kg/im or iv once a day
Cotrimoxazole trimethoprim (TMP) 8mg/kg/dose + sulfamethoxazole (SMX) 40mg/kg/dose three times daily
Prednisolone 2mg/kg during 7 days, plus 1mg/kg other 7 days, plus 0.5 mg/kg for 7 days |
Antibiotics: 5 days.
Cotrimoxazole trimethoprim: 21 days.
Prednisolone: 21 days. |
Standard treatment for severe pneumonia in HIV-infected children includes broad-spectrum antibiotics for bacteria and cotrimoxazole plus prednisolone for P. jirovecii. |
156 |
Active-Treatment of Control Group |
Experimental Group |
TBT plus Standard of Care |
Isoniazid 10 mg/kg (range 7–15 mg/kg)/day; maximum dose 300 mg/day for 6 months.
Rifampicin 15 mg/kg (range 10–20 mg/kg)/day; maximum dose 600 mg/day for 6 months.
Pyrazinamide 35 mg/kg (range 30–40 mg/kg)/day for 2 months.
Ethambutol 20 mg/kg (range 15–25 mg/kg)/day for 2 months
Plus Standard of Care described in the Control Group
|
Isoniazid, 6 months
Rifampicin, 6 months
Pyrazinamide, 2 months
Ethambutol, 2 months
Plus Standard of Care described in the Control Group |
Empirical treatment with drugs against tuberculosis:
Fixed-dose dispersible tablet of rifampicin, isoniazid, pyrazinamide (75/50/150 mg)
Fixed-dose dispersible tablet of rifampicin/isoniazid (75/50 mg)
Ethambutol 100 mg dispersible tablet |
156 |
|
Experimental Group |
Valganciclovir plus Standard of Care |
16 mg/kg/12 hours
Plus Standard or Care described in Control Group |
15 days |
Valganciclovir (powder for suspension, 50 mg/mL) oral, 16 mg/kg/12 hours for 15 days
Plus Standard or Care described in Control Group |
156 |
|
Experimental Group |
TBT plus Valganciclovir plus SoC |
Isoniazid 10 mg/kg (range 7–15 mg/kg)/day; maximum dose 300 mg/day for 6 months.
Rifampicin 15 mg/kg (range 10–20 mg/kg)/day; maximum dose 600 mg/day for 6 months.
Pyrazinamide 35 mg/kg (range 30–40 mg/kg)/day for 2 months.
Ethambutol 20 mg/kg (range 15–25 mg/kg)/day for 2 months
Valganciclovir (powder for suspension, 50 mg/mL) oral, 16 mg/kg/12 hours for 15 days
Plus Standard of Care described in the Control GroupPlus Standard or Care described in Control Group |
Isoniazid, 6 months
Rifampicin, 6 months
Pyrazinamide, 2 months
Ethambutol, 2 months
Valganciclovir, 15 days
Plus Standard of Care described in the Control Group |
Empirical treatment with drugs against tuberculosis and against CMV:
Fixed-dose dispersible tablet of rifampicin, isoniazid, pyrazinamide (75/50/150 mg)
Fixed-dose dispersible tablet of rifampicin/isoniazid (75/50 mg)
Ethambutol 100 mg dispersible tablet
Valganciclovir (powder for suspension, 50 mg/mL) oral, 16 mg/kg/12 hours for 15 days
Plus Standard or Care described in Control Group |
156 |
|