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| Name | Class |
|---|---|
| University of Oxford | OTHER |
| Patan Academy of Health Sciences, Nepal | UNKNOWN |
| Patan Hospital, Nepal | UNKNOWN |
| Civil Hospital, Nepal |
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The investigators aim to compare two antibiotic treatments for enteric (typhoid) fever. Three hundred patients at Patan Hospital will be enrolled in the study. Patients will be assigned to one of the two treatments by chance and followed for 6 months. The two treatment groups will be compared to see which treatment is more likely to make the patient better.
With the study hypothesis that Gatifloxacin is superior to Ceftriaxone in terms of treatment failure in patients with enteric fever, a comparative study will be conducted at Patan Hospital. 300 patients who are diagnosed with enteric fever will be enrolled into the study. The patients will be randomized to one of two groups. One group will receive treatment with Gatifloxacin for 7 days, and the other with Ceftriaxone. The patients will be followed during the treatment courses and at several points of 6 months after initial presentation. The endpoints then will be compared between two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gatifloxacin | Active Comparator | Gatifloxacin 10mg/kg/day for 7 days |
|
| Ceftriaxone | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftriaxone | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of treatment failure | Any one (1) of the following defines treatment failure:
| upon occurance, within 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| S.typhi or S.paratyphi carriage | Stool culture positive for S.typhi or S.paratyphi carriage | 1 month, 3 months and 6 months |
| Number of adverse events | Treatment tolerance as defined by the number of adverse events, serious adverse events and disease complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Buddha Basnyat, MD | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Civil Hospital | Kathmandu | Nepal | ||||
| Patan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26809813 | Derived | Arjyal A, Basnyat B, Nhan HT, Koirala S, Giri A, Joshi N, Shakya M, Pathak KR, Mahat SP, Prajapati SP, Adhikari N, Thapa R, Merson L, Gajurel D, Lamsal K, Lamsal D, Yadav BK, Shah G, Shrestha P, Dongol S, Karkey A, Thompson CN, Thieu NTV, Thanh DP, Baker S, Thwaites GE, Wolbers M, Dolecek C. Gatifloxacin versus ceftriaxone for uncomplicated enteric fever in Nepal: an open-label, two-centre, randomised controlled trial. Lancet Infect Dis. 2016 May;16(5):535-545. doi: 10.1016/S1473-3099(15)00530-7. Epub 2016 Jan 20. |
| Label | URL |
|---|---|
| Oxford University Clinical Research Unit, Viet Nam | View source |
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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 |
|---|---|
| D002443 | Ceftriaxone |
| D000077734 | Gatifloxacin |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
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| UNKNOWN |
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| Gatifloxacin | Drug | Gatifloxacin 10 mg/kg/day for 7 days. Tablets for oral administration. |
|
| within 6 months |
| Household transmission | Total number of febrile episodes, hospital visits and hospital admissions within household members | within 6 months |
| Time to fever clearance | Time from first dose of treatment until a temperature which is ≤37•5°C for a 48 hour period is first recorded. | upon occurance, within 7 days |
| Rate of culture-positive and syndromic clinical relapses | within 28 days of starting therapy |
| Rate of relapses confirmed using additional diagnostic techniques | Additional techniques will include culture-PCR and gene expression profiling. | within 28 days of starting therapy |
| Kathmandu |
| Nepal |
| Oxford University Clinical Research Unit, Nepal | View source |
| Trial Ethical Approval letters and Informed Consent Forms | View source |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D007769 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |