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This study evaluates whether XDR Typhoid fever in children can be effectively treated with monotherapy (meropenum alone), or a combination (meropenum and azithromycin).
Complicated XDR Enteric fever is a very serious systemic disease, caused by an extremely resistant mutant strain of Salmonella Typhi ( the H58 S. Typhi superbug,) that as the name suggests is resistant to not only the first but also the second tier drugs conventionally used for treatment of the same. And as such, warrants immediate antibiotic therapy, but in view of the extended antimicrobial resistance the treatment options are limited to only two effective drugs viz Carbepenem and Azithromycin, as per culture sensitivity.
So far, in the absence of universal standardized treatment protocols for XDR complicated typhoid fever in children, random use of either one or both in combination is the current practice.
However, keeping antibiotic stewardship in mind, it is imperative to ascertain whether meropenum alone is effective or should be combined with azithromycin in the treatment of this serious disease.
Our study therefore compares the efficacy of monotherapy with meropenum or combination with azithromycin based on clinical and microbiologic remission, shortened hospital stay and less chances of relapse in order to then formulate a standardized protocol to treat complicated XDR typhoid in children thus preventing yet further antimicrobial resistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| meropenum and azithromycin group | Experimental | inj meropenum 20mg/kg/dose I/v in 3 divided doses and syp azithromycin 20mg/kg/day in 2 divided doses. |
|
| meropenum group | Active Comparator | inj meropenum 20mg/kg/dose I/v in 3 divided doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meropenem Injection | Drug | inj meropenum for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical clearance | improvement of the signs and symptoms as given in the operational definition | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| bacterial clearance | negative blood cultures | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| relapse of typhoid fever | reappearance of the signs and symptoms of typhoid fever along with positive blood cultures | 15 days after completing treatment |
Inclusion Criteria:
Patients with extended drug resistant typhoid fever defined as culture proven typhoid fever caused by Salmonella Typhi or Para typhi resistant to Ampicillin, Chloramphenicol,Co trimoxazole,Quinolones and Ceftriaxone along with two or more of the following condition
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| farhana zafar, mbbs,fcps | ziauddin university north campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziauddin University | Karachi | Sindh | 75600 | Pakistan |
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| ID | Term |
|---|---|
| D014435 | Typhoid Fever |
| ID | Term |
|---|---|
| D012480 | Salmonella Infections |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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| Azithromycin Powder | Drug | syp azithromycin for10days |
|
|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |