Typhoid Fever
Conditions
Keywords
XDR TYPHOID FEVER
Brief summary
This study evaluates whether XDR Typhoid fever in children can be effectively treated with monotherapy (meropenum alone), or a combination (meropenum and azithromycin).
Detailed description
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.
Interventions
inj meropenum for 10 days
syp azithromycin for10days
Sponsors
Ziauddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
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 * High grade fever spikes for more than three days * Refusal to eat or drink * Drowsy or Unconscious * Convulsions * Dehydration due to diarrhea or vomiting * Abdominal distension with or without tenderness * Bleeding diathesis like petechial rash, gum bleed, melena * Jaundice or alanine transaminase more than twice of the normal range * Thrombocytopenia less than fifty thousand * Increase Prothrombin time and activated partial thromboplastin time * Electrolyte imbalance like hyponatremia, hypernatremia, hypokalemia, hyperkalemia, metabolic acidosis * Hypoglycemia * Signs of shock like cold and mottled skin, feeble pulses, tachycardia, decreased blood pressure
Exclusion criteria
* Not given informed consent * Children who need ventilator or two inotrope support * Severe malnutrition/immunocompromised patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical clearance | 10 days | improvement of the signs and symptoms as given in the operational definition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bacterial clearance | 5 days | negative blood cultures |
Other
| Measure | Time frame | Description |
|---|---|---|
| relapse of typhoid fever | 15 days after completing treatment | reappearance of the signs and symptoms of typhoid fever along with positive blood cultures |
Countries
Pakistan
Outcome results
None listed