Typhoid FeverPhase 4[XDRTYPHOID]NCT04154722
Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children
A Phase 4 study testing Meropenem Injection and Azithromycin Powder in people with Typhoid Fever, run by Ziauddin University at 1 site in Pakistan.
Trial summary
This study evaluates whether XDR Typhoid fever in children can be effectively treated with monotherapy (meropenum alone), or a combination (meropenum and azithromycin). Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Typhoid Fever
- What is being tested?
- Meropenem Injection and Azithromycin Powder
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jun 2019to 30 Dec 2020
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Not given informed consent
- Children who need ventilator or two inotrope support
- Severe malnutrition/immunocompromised patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of 21st Century Typhoid Fever in Children;Open Label Mono vs Combination Drug Therapy
This study evaluates whether XDR Typhoid fever in children can be effectively treated with monotherapy (meropenum alone), or a combination (meropenum and azithromycin).
Read the 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.
- Conditions
- Typhoid Fever
- Being tested
- Meropenem Injection, Azithromycin Powder
- Keywords
- XDR 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.
Meropenem InjectionDrug
Also called meroneum, penro
inj meropenum for 10 days
Azithromycin PowderDrug
Also called azomax, zetro
syp azithromycin for10days
| Study group | Role | What they receive |
|---|---|---|
| meropenum and azithromycin group | Experimental | inj meropenum 20mg/kg/dose I/v in 3 divided doses and syp azithromycin 20mg/kg/day in 2 divided doses. Receives: Drug: Meropenem Injection; Drug: Azithromycin Powder |
| meropenum group | Active comparator | inj meropenum 20mg/kg/dose I/v in 3 divided doses Receives: Drug: Meropenem Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical clearance
improvement of the signs and symptoms as given in the operational definition
Measured: 10 days
Secondary outcomes (1)
bacterial clearance
negative blood cultures
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 posted6 Nov 2019
- Study start20 Jun 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Typhoid FeverStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fatima G Siddiqi, Ziauddin University
- Investigators
- farhana zafar, mbbs,fcps, Principal investigator, ziauddin university north campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154722
- Sponsor's protocol ID
- 0980419HRPED
- Acronym
- [XDRTYPHOID]
- Status last verified
- Jun 2021
- First submitted
- 4 Nov 2019
- Last updated
- 16 Jun 2021
- Results posted
- 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 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of 21st Century Typhoid Fever in Children;Open Label Mono vs Combination Drug Therapy
- ClinicalTrials.gov ID
- NCT04154722
- Acronym / sponsor ID
- [XDRTYPHOID] / 0980419HRPED
- Conditions
- Typhoid Fever
- Keywords
- XDR TYPHOID FEVER
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 6 Nov 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| meropenum and azithromycin group | Experimental | Drug: Meropenem Injection, Drug: Azithromycin Powderinj meropenum 20mg/kg/dose I/v in 3 divided doses and syp azithromycin 20mg/kg/day in 2 divided doses. |
| meropenum group | Active comparator | Drug: Meropenem Injectioninj meropenum 20mg/kg/dose I/v in 3 divided doses |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (3 listed)
- Not given informed consent
- Children who need ventilator or two inotrope support
- Severe malnutrition/immunocompromised patient
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 |
|---|---|---|
| Meropenem InjectionAlso: meroneum, penroinj meropenum for 10 days | Drug | meropenum and azithromycin group, meropenum group |
| Azithromycin PowderAlso: azomax, zetrosyp azithromycin for10days | Drug | meropenum and azithromycin group |
Primary outcome
clinical clearance
Time frame: 10 days
improvement of the signs and symptoms as given in the operational definition
1 secondary outcome
bacterial clearance
Time frame: 5 days
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 16 Jun 2021.
- Individual participant dataSharing planned: No
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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.
farhana zafar, mbbs,fcps principal investigator
ziauddin university north campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meropenem Injection and Azithromycin Powder in people with Typhoid Fever, run by Ziauddin University 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 14 inclusion and 3 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 16 Jun 2021. 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 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?
clinical clearance (time frame: 10 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 16 Jun 2021.