NCT02224040

Brief Summary

The current study goal is to examine the effect of Cephalosporins, Azithromycin and the combination of both on typhoid fever therapy in endemic population. The investigator's hypothesize that the combination of azithromycin and ceftriaxone may prove superior to each drug, ceftriaxone or azithromycin, alone.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 27, 2014

Status Verified

August 1, 2014

Enrollment Period

1.3 years

First QC Date

August 21, 2014

Last Update Submit

August 26, 2014

Conditions

Typhoid Fever

Outcome Measures

Primary Outcomes (1)

  • Fever clearance time

    Time to fever clearance will be measured and will be defined as an oral temperature that is below 37.50 C

    One month

Secondary Outcomes (1)

  • Treatment failure

    One month

Study Arms (4)

Ceftriaxone I.V

EXPERIMENTAL

The participants in this arm will receive the following drug and dosage: adult: Ceftriaxone intravenous 2 gr once a day. Pediatric: intravenous 75 mg/kg ceftriaxone once a day (maximum dose 2.5 g/day). Patients will receive antibiotic treatment until defervescence and for 3 days afterwards. Patients will be hospitalized during the entire treatment course (including the afebrile period).

Drug: ceftriaxone

Ceftriaxone I.V+Azithromycin P.O

EXPERIMENTAL

The participants in this arm will receive the following drugs and dosages: adult: 2 g intravenous ceftriaxone and 500 mg oral azithromycin once a day. Pediatric: intravenous 75 mg/kg ceftriaxone once a day and oral 20 mg/kg azithromycin suspension once a day. Patients will receive antibiotic treatment until defervescence and for 3 days afterwards. Patients will be hospitalized during the entire treatment course (including the afebrile period).

Drug: ceftriaxone and azithromycin

Azithromycin P.O

EXPERIMENTAL

The participants in this arm will receive the following drug and dosage: adult: azithromycin oral 500 mg once a day. Pediatric: oral 20 mg/kg azithromycin suspension once a day (maximum dose 1000 mg/day). Patients will receive antibiotic treatment until defervescence and for 3 days afterwards.

Drug: azithromycin

Azithromycin P.O+Cefixime P.O

EXPERIMENTAL

The participants in this arm will receive the following drugs and dosages: adult: 500 mg azithromycin and 400 mg cefixime. Pediatric: oral 20 mg/kg azithromycin suspension once a day and oral 10 mg/kg cefixime. Patients will receive antibiotic treatment until defervescence and for 3 days afterwards.

Drug: azithromycin and cefixime

Interventions

ceftriaxoneDRUG
Ceftriaxone I.V
ceftriaxone and azithromycinDRUG
Ceftriaxone I.V+Azithromycin P.O
azithromycinDRUG
Azithromycin P.O
azithromycin and cefiximeDRUG
Azithromycin P.O+Cefixime P.O

Eligibility Criteria

Age2 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Blood culture-proven typhoid fever (S. typhi or S. paratyphi)
  • Signed informed consent to participate in the study.

You may not qualify if:

  • Allergy to ceftriaxone or macrolides
  • Major typhoid fever-associated complications
  • Inability to swallow oral medication
  • Underlying illness
  • Pregnancy
  • Lactation
  • Treatment within the past 4 days with an antibiotic that may be effective against typhoid fever

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dhulikhel hospital

Dhulikhel, 11008, Nepal

RECRUITING

Related Publications (1)

  • Zmora N, Shrestha S, Neuberger A, Paran Y, Tamrakar R, Shrestha A, Madhup SK, Bedi TRS, Koju R, Schwartz E. Open label comparative trial of mono versus dual antibiotic therapy for Typhoid Fever in adults. PLoS Negl Trop Dis. 2018 Apr 23;12(4):e0006380. doi: 10.1371/journal.pntd.0006380. eCollection 2018 Apr.

    PMID: 29684022DERIVED

MeSH Terms

Conditions

Typhoid Fever

Interventions

CeftriaxoneAzithromycinCefixime

Condition Hierarchy (Ancestors)

Salmonella InfectionsEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactones

Study Officials

  • Eli Schwartz, MD, DTMH

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eli Schwartz, MD, DTMH

CONTACT

+97235308456Eli.schwartz@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator of the geographic clinical

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 22, 2014

Study Start

August 1, 2013

Primary Completion

December 1, 2014

Study Completion

August 1, 2015

Last Updated

August 27, 2014

Record last verified: 2014-08

Locations

NE(1)