Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 110/SZMC/SZH | Other Identifier | Institutional Review Board, Sheikh Zayed Medical College and Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized controlled trial evaluates the comparative efficacy of intravenous meropenem alone versus intravenous meropenem combined with oral azithromycin in children aged 6 months to under 5 years diagnosed with blood culture-confirmed extensively drug-resistant uncomplicated typhoid fever. A total of 90 participants are randomly assigned in a 1:1 ratio to receive either meropenem monotherapy or combination therapy. The primary outcome is time to defervescence, defined as the number of days required for body temperature to fall below 100°F and remain so for at least 48 consecutive hours after initiation of antibiotic treatment. Participants are monitored daily during hospitalization for clinical improvement and adverse drug reactions
This interventional randomized controlled trial compares intravenous meropenem alone with intravenous meropenem combined with oral azithromycin for the treatment of extensively drug-resistant uncomplicated typhoid fever in children aged 6 months to under 5 years. A total of 90 participants are randomly assigned in equal numbers to receive either meropenem monotherapy or combination therapy. The primary outcome measure is time to defervescence, defined as the time from initiation of antibiotic treatment to reduction of axillary temperature below 100°F maintained for at least 48 consecutive hours. Participants are monitored daily during hospitalization for clinical response and adverse events.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meropenem Monotherapy | Experimental | Participants receive intravenous meropenem at a dose of 20-40 mg/kg every 8 hours. |
|
| Meropenem Plus Azithromycin | Experimental | Participants receive intravenous meropenem (20-40 mg/kg every 8 hours) combined with oral azithromycin at a dose of 20 mg/kg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meropenem | Drug | Intravenous meropenem administered at a dose of 20-40 mg/kg every 8 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Defervescence | Time to defervescence is defined as the number of days from initiation of antibiotic therapy until the axillary body temperature falls below 100°F and remains below this threshold for at least 48 consecutive hours. | From initiation of antibiotic treatment until achievement of sustained defervescence (up to 14 days) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheikh Zayed Hospital, Rahim Yar Khan, Pakistan | Rahim Yar Khan | Punjab Province | 64200 | Pakistan |
Not provided
Participants were randomly assigned in parallel groups to receive either meropenem monotherapy or meropenem combined with azithromycin.
Not provided
Not provided
Not provided
Not provided
| Azithromycin + Metronidazole | Drug | Participants receive intravenous meropenem (20-40 mg/kg every 8 hours) combined with oral azithromycin at a dose of 20 mg/kg/day. |
|
| ID | Term |
|---|---|
| D014435 | Typhoid Fever |
| ID | Term |
|---|---|
| D012480 | Salmonella Infections |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077731 | Meropenem |
| D017963 | Azithromycin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided