TyphoidPhase 2NCT07150065
Efficacy of Levofloxacin Versus Ciprofloxacin in the Treatment of Childhood Typhoid Fever
A Phase 2 study testing Levofloxacin and ciprofloxacin in people with Typhoid and Fever, run by Avicenna Medical College Lahore at 1 site in Pakistan.
Trial summary
Sample size of 360 children with typhoid fever were enrolled and randomly divided in two groups. All the children were enrolled in the trial from Pediatrics emergency. Informed consent was obtained from parents. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- What is being tested?
- Levofloxacin and ciprofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Feb 2025to 7 Aug 2025
- Phase
- Phase 2
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of age 1-12 years
- Typhoid fever
- Confirmed on blood culture
Who cannot join
- Recurrent typhoid within 3 months
- Intestinal perforation
- Evidence of progressive or complicated disease
- Inability to swallow oral medication
- Hypersensitivity to trial drugs
- Already taken fluoroquinolone, third generation cephalosporin or macrolide in last week
Trial locations and contacts
1 site in 1 country.
About this study
Sample size of 360 children with typhoid fever were enrolled and randomly divided in two groups. All the children were enrolled in the trial from Pediatrics emergency. Informed consent was obtained from parents. Demographics (name, age of child, sex of the child, duration of fever, weight, season, socioeconomic status and residence) were noted. Then children were admitted and randomly divided in two groups by using lottery method. In group A, children were given oral 200 mg levofloxacin tablet. In group B, children were given oral 900-1,000 mg ciprofloxacin tablet. All children were followed-up pediatric wards for 7 days. If fever was resolved within 5 days (body temperature falls <99oF and remain stable for at least 5 days), then efficacy was labeled. Total time required to resolve fever i.e. body temperature <99oF in all children was also noted. All this information was recorded
- Being tested
- Levofloxacin, ciprofloxacin
- Keywords
- ciprofloxacin, children, enteric fever, levofloxacin
- Medical subject headings
- Typhoid Fever, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
Oral 200 mg levofloxacin tablet
ciprofloxacinDrug
Oral 900-1,000 mg ciprofloxacin tablet
| Study group | Role | What they receive |
|---|---|---|
| Group A with oral 200 mg levofloxacin tablet | Active comparator | Group A included 180 participants. They were given oral 200 mg levofloxacin tablet. All children were followed-up pediatric wards for 7 days. If fever was resolved within 5 days (body temperature falls <99oF and remain stable for at least 5 days), then efficacy was labeled. Total time required to resolve fever i.e. body temperature <99oF in all children was also noted. Receives: Drug: Levofloxacin |
| Group B with oral 900-1,000 mg ciprofloxacin tablet | Active comparator | . In group B, children were given oral 900-1,000 mg ciprofloxacin tablet. All children were followed-up pediatric wards for 7 days. If fever was resolved within 5 days (body temperature falls <99oF and remain stable for at least 5 days), then efficacy was labeled. Total time required to resolve fever i.e. body temperature <99oF in all children was also noted Receives: Drug: ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time required to resolve fever
Clinical efficacy involved resolution of fever within 5 days (body temperature falls <99oF and remain stable for at least 5 days). Total time required to resolve fever i.e. body temperature <99oF in all children was also noted.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start7 Feb 2025
- Primary completion7 Aug 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TyphoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avicenna Medical College Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Iqbal, Avicenna Medical College Lahore
- Investigators
- Professor Aneela Zareen, MBBS FCPS, Study director, Avicenna Medical And Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150065
- Sponsor's protocol ID
- 107
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Levofloxacin Versus Ciprofloxacin in the Treatment of Childhood Typhoid Fever
- ClinicalTrials.gov ID
- NCT07150065
- Acronym / sponsor ID
- 107
- Keywords
- ciprofloxacin, children, enteric fever, levofloxacin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Avicenna Medical College LahoreUniversity, hospital or other
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sample size of 360 children with typhoid fever were enrolled and randomly divided in two groups. All the children were enrolled in the trial from Pediatrics emergency. Informed consent was obtained from parents. Demographics (name, age of child, sex of the child, duration of fever, weight, season, socioeconomic status and residence) were noted. Then children were admitted and randomly divided in two groups by using lottery method. In group A, children were given oral 200 mg levofloxacin tablet. In group B, children were given oral 900-1,000 mg ciprofloxacin tablet. All children were followed-up pediatric wards for 7 days. If fever was resolved within 5 days (body temperature falls <99oF and remain stable for at least 5 days), then efficacy was labeled. Total time required to resolve fever i.e. body temperature <99oF in all children was also noted. All this information was recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A with oral 200 mg levofloxacin tablet | Active comparator | Drug: LevofloxacinGroup A included 180 participants. They were given oral 200 mg levofloxacin tablet. All children were followed-up pediatric wards for 7 days. If fever was resolved within 5 days (body temperature falls <99oF and remain stable for at least 5 days), then efficacy was labeled. Total time required to resolve fever i.e. body temperature <99oF in all children was also noted. |
| Group B with oral 900-1,000 mg ciprofloxacin tablet | Active comparator | Drug: ciprofloxacin. In group B, children were given oral 900-1,000 mg ciprofloxacin tablet. All children were followed-up pediatric wards for 7 days. If fever was resolved within 5 days (body temperature falls <99oF and remain stable for at least 5 days), then efficacy was labeled. Total time required to resolve fever i.e. body temperature <99oF in all children was also noted |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children of age 1-12 years
- Typhoid fever
- Confirmed on blood culture
Key exclusion criteria (6 listed)
- Recurrent typhoid within 3 months
- Intestinal perforation
- Evidence of progressive or complicated disease
- Inability to swallow oral medication
- Hypersensitivity to trial drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevofloxacinOral 200 mg levofloxacin tablet | Drug | Group A with oral 200 mg levofloxacin tablet |
| ciprofloxacinOral 900-1,000 mg ciprofloxacin tablet | Drug | Group B with oral 900-1,000 mg ciprofloxacin tablet |
Primary outcome
Total time required to resolve fever
Time frame: 5 days
Clinical efficacy involved resolution of fever within 5 days (body temperature falls <99oF and remain stable for at least 5 days). Total time required to resolve fever i.e. body temperature <99oF in all children was also noted.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Typhoid
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Curcumin Extract Added to Ciprofloxacin for Typhoid Carriers Among Food Handlers of the Free Nutritious Meal Program
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Opportunistic Pneumococcal Immunisation Trial in MALnutrition
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CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera
Typhoid and/or Cholera Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Aneela Zareen, MBBS FCPS study director
Avicenna Medical And Dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levofloxacin and ciprofloxacin in people with Typhoid and Fever, run by Avicenna Medical College Lahore at 1 site in Pakistan.
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 3 inclusion and 6 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 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Total time required to resolve fever (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2025.