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Enteric FeverPhase 4NCT01421693

Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

A Phase 4 study testing Ceftriaxone and Gatifloxacin in people with Enteric Fever and Typhoid Fever, run by Oxford University Clinical Research Unit, Vietnam at 2 sites in Nepal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 2 to 45 years
Conditions the study is for
Enteric Fever, Typhoid Fever
What is being tested?
Ceftriaxone and Gatifloxacin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
2 sitesNepal
Study dates
Sep 2011to Jan 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Suspected or culture proven enteric fever
  • >= 2 <= 45 years of age
  • Fever >= 38°C for >= 4 days
  • Informed consent to participate in the study

Who cannot join

  • Pregnancy
  • Obtundation
  • Shock
  • Visible jaundice
  • Presence of signs of gastrointestinal bleeding
  • Evidence of severe disease
Show all 9Show fewer
  • Diabetes
  • History of hypersensitivity to either of the trial drugs
  • Known previous treatment with a quinolone antibiotic or 3rd generation cephalosporin or macrolide within one week of hospital admission.

Trial locations and contacts

2 sites in 1 country.

Nepal2 sites

  • Civil Hospital

    Kathmandu

  • Patan Hospital

    Kathmandu

Other trials in Nepal

About this study

Official title: Randomized, Open-label, Superiority Trial of the Effectiveness of Gatifloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Enteric Fever.

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.

Read the detailed description

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.

Being tested
Ceftriaxone, Gatifloxacin
Keywords
Gatifloxacin, Ceftriaxone, Enteric fever, Typhoid fever
Medical subject headings
Typhoid Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CeftriaxoneDrug

    • ≥2-<14 years - 60mg/kg/ once daily for 7 days
    • 14 years and older - 2g once daily for 7 days
    • Intravenous infusion. Vials of crystalline powder.

  • GatifloxacinDrug

    Gatifloxacin 10 mg/kg/day for 7 days. Tablets for oral administration.

Study groups in NCT01421693
Study groupRoleWhat they receive
GatifloxacinActive comparatorGatifloxacin 10mg/kg/day for 7 days
Receives: Drug: Gatifloxacin
CeftriaxoneActive comparator* ≥2-<14 years - 60mg/kg/ once daily for 7 days * 14 years and older - 2g once daily for 7 days
Receives: Drug: Ceftriaxone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of treatment failure

    Any one (1) of the following defines treatment failure:

    • Fever clearance time >7 x 24hours post treatment initiation
    • Blood culture positive at Day 8 of treatment (microbiological failure)
    • Requirement of rescue treatment
    • Culture confirmed or syndromic relapse within 28 days of initiation of treatment
    • The development on treatment of any enteric fever related complication within 28 days of initiation of treatment including, clinically significant bleeding, fall in the Glasgow Coma Score, perforation of the gastrointestinal tract or admission to hospital Both the absolute risk of treatment failure and the time to treatment failure will be analyzed

    Measured: upon occurance, within 28 days

Secondary outcomes (6)

  1. S.typhi or S.paratyphi carriage

    Stool culture positive for S.typhi or S.paratyphi carriage

    Measured: 1 month, 3 months and 6 months

  2. Number of adverse events

    Treatment tolerance as defined by the number of adverse events, serious adverse events and disease complications

    Measured: within 6 months

  3. Household transmission

    Total number of febrile episodes, hospital visits and hospital admissions within household members

    Measured: within 6 months

  4. 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.

    Measured: upon occurance, within 7 days

  5. Rate of culture-positive and syndromic clinical relapses

    Measured: within 28 days of starting therapy

  6. Rate of relapses confirmed using additional diagnostic techniques

    Additional techniques will include culture-PCR and gene expression profiling.

    Measured: within 28 days of starting therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionJul 2014
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01421693
Sponsor's protocol ID
03NP
Status last verified
Oct 2016
First submitted
22 Aug 2011
Last updated
4 Oct 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26809813

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ceftriaxone and Gatifloxacin in people with Enteric Fever and Typhoid Fever, run by Oxford University Clinical Research Unit, Vietnam at 2 sites in Nepal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of treatment failure (time frame: upon occurance, within 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01421693, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.

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