Multi Drug Resistant InfectionsPhase 4NCT07258225
Clinical Effectiveness of a Once-daily Regimen of Tigecycline Compared to the Standard Regimen
A Phase 4 study testing Tigecycline once daily regimen and Usual doses of tigecycline in people with Multi Drug Resistant Infections, run by Air Force Specialized Hospital, Cairo, Egypt at 1 site in Egypt.
Trial summary
To compare the clinical response (efficacy) and the safety of the tigecycline once daily regimen versus the standard regimen (twice daily regimen). Clinical response was categorized as a cure, failure of treatment, or indeterminate outcome.24 Treatment success (Cure): defined as resolution of signs/symptoms of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi Drug Resistant Infections
- What is being tested?
- Tigecycline once daily regimen and Usual doses of tigecycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 30 Apr 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Both males and females.
- Diagnosis of infection has been established and tigecycline use is indicated (intra-abdominal, community-acquired pneumonia, skin Infections) or based on genetic testing and microbiological cultures (MDR Acinetobacter, MDR Stenotrophomonas, MDR Enterobacteriaceae, etc.)
Who cannot join
- Pregnancy and lactation.
- Bloodstream infections (BSI) and urinary tract infections (UTIs).
- Refusal of attending staff or patient, or family.
- Contraindications to tigecycline, such as hypersensitivity and allergy.
- Patients receiving ≤ 1 day of tigecycline (insufficient length of therapy).
- Patients who have acute physiology and chronic health evaluation (APACHE 2) score of more than 35 (high risk of mortality).
- Do not resuscitate/do not intubate (DNR, DNI) patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effectiveness of a Once-daily Regimen of Tigecycline Compared to the Standard Regimen in Critically Ill Patients
To compare the clinical response (efficacy) and the safety of the tigecycline once daily regimen versus the standard regimen (twice daily regimen). Clinical response was categorized as a cure, failure of treatment, or indeterminate outcome.24 Treatment success (Cure): defined as resolution of signs/symptoms of infection, microbiological cure (negative cultures after tigecycline use), improvement of infection markers (leukocytic count, C reactive protein, and procalcitonin).
Treatment failure: defined as persistence of signs/symptoms of infection despite antimicrobial therapy, deterioration of infection markers (leukocytic count, C reactive protein, and Procalcitonin).
Indeterminate response: subjects who do not have an outcome determination for reasons unrelated to the study drug or infection (e.g., loss to follow-up, withdrawal of consent, etc.) Safety will be assessed by the incidence of adverse events especially which leads to treatment discontinuation.36
- Conditions
- Multi Drug Resistant Infections
- Being tested
- Tigecycline once daily regimen, Usual doses of tigecycline
- Keywords
- Once daily tigecycline, High dose tigecycline, Tigecycline safety, Tigecycline efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tigecycline once daily regimenDrug
Tigecycline once-daily regimen (100 mg once daily) or (200 mg once daily). For hepatic patients with a Child-Pugh score (C), the loading dose is 100 mg, then 50 mg every 24 hours.
Usual doses of tigecyclineDrug
Tigecycline standard dose (100 mg loading dose then 50 mg every 12 hours) or (200 mg loading dose then 100 mg every 12 hours). For hepatic patients with Child-Pugh score (C), the loading dose is 100 mg then 25 mg every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Control arm : Usual doses of tigecycline | Active comparator | Tigecycline standard dose (100 mg loading dose then 50 mg every 12 hours) or (200 mg loading dose then 100 mg every 12 hours). For hepatic patients with a Child-Pugh score (C), the loading dose is 100 mg, then 25 mg every 12 hours Receives: Drug: Usual doses of tigecycline |
| Tigecycline once daily regimen | Experimental | Tigecycline once-daily regimen (100 mg once daily) or (200 mg once daily). For hepatic patients with Child-Pugh score (C), the loading dose is 100 mg then 50 mg every 24 hours. Receives: Drug: Tigecycline once daily regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare treatment outcomes (clinical response) of the tigecycline once-daily regimen and the standard regimen (twice-daily regimen). composite endpoint
Composite clinical response, defined as improvement of inflammatory markers (CRP, Procalcitonin), clinical improvement permitting ICU discharge, and absence of need to modify tigecycline therapy (no escalation or addition of other antibiotics), will be assessed at different time points during the study period. The response is classified as 1- Treatment success (Cure) by improvement of the SOFA score, improvement of infection markers ( CRP, Procalcitonin), and by the need for ICU stay ( ICU length of stay) 2- Treatment failure by an increase of SOFA score, an increase of infection markers ( CRP, Procalcitonin), need to change tigecycline to another antibiotic, or to add on another antibiotic, and death 3) Indeterminate response for drop-out patients and incomplete minimal duration of therapy
Measured: 28 days
Compare the safety of the tigecycline once-daily regimen and the standard regimen (twice-daily regimen).
- Tigecycline-induced hyperbilirubinemia will be assessed by comparing the baseline bilirubin level to the follow-up level at determined intervals (3 days, 5 days), allowing for comparison of the incidence of hyperbilirubinemia between the two study groups.
.
Measured: 28 days
Secondary outcomes (4)
- Intensive care unit (ICU) and in-hospital mortality between the two groups.
Calculate the percentage of dead patients in the two groups
Measured: 28 days
Infection markers change between the two groups (C-reactive protein (CRP)
Comparing the increase or decrease in CRP level (mg/L)
Measured: 28 days
Vasopressor needs (only in septic shock patients).
Comparing the duration of vasopressor need between the two groups
Measured: 28 days
Compare the incidence of tigecycline-induced vomiting between the two groups
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Apr 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi Drug Resistant InfectionsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Specialized Hospital, Cairo, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258225
- Sponsor's protocol ID
- 1.2025
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of a Once-daily Regimen of Tigecycline Compared to the Standard Regimen in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07258225
- Acronym / sponsor ID
- 1.2025
- Conditions
- Multi Drug Resistant Infections
- Keywords
- Once daily tigecycline, High dose tigecycline, Tigecycline safety, Tigecycline efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Air Force Specialized Hospital, Cairo, EgyptUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 2 Dec 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.
To compare the clinical response (efficacy) and the safety of the tigecycline once daily regimen versus the standard regimen (twice daily regimen). Clinical response was categorized as a cure, failure of treatment, or indeterminate outcome.24 Treatment success (Cure): defined as resolution of signs/symptoms of infection, microbiological cure (negative cultures after tigecycline use), improvement of infection markers (leukocytic count, C reactive protein, and procalcitonin).
Treatment failure: defined as persistence of signs/symptoms of infection despite antimicrobial therapy, deterioration of infection markers (leukocytic count, C reactive protein, and Procalcitonin).
Indeterminate response: subjects who do not have an outcome determination for reasons unrelated to the study drug or infection (e.g., loss to follow-up, withdrawal of consent, etc.) Safety will be assessed by the incidence of adverse events especially which leads to treatment discontinuation.36
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm : Usual doses of tigecycline | Active comparator | Drug: Usual doses of tigecyclineTigecycline standard dose (100 mg loading dose then 50 mg every 12 hours) or (200 mg loading dose then 100 mg every 12 hours). For hepatic patients with a Child-Pugh score (C), the loading dose is 100 mg, then 25 mg every 12 hours |
| Tigecycline once daily regimen | Experimental | Drug: Tigecycline once daily regimenTigecycline once-daily regimen (100 mg once daily) or (200 mg once daily). For hepatic patients with Child-Pugh score (C), the loading dose is 100 mg then 50 mg every 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Both males and females.
- Diagnosis of infection has been established and tigecycline use is indicated (intra-abdominal, community-acquired pneumonia, skin Infections) or based on genetic testing and microbiological cultures (MDR Acinetobacter, MDR Stenotrophomonas, MDR Enterobacteriaceae, etc.)
Key exclusion criteria (7 listed)
- Pregnancy and lactation.
- Bloodstream infections (BSI) and urinary tract infections (UTIs).
- Refusal of attending staff or patient, or family.
- Contraindications to tigecycline, such as hypersensitivity and allergy.
- Patients receiving ≤ 1 day of tigecycline (insufficient length of therapy).
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 |
|---|---|---|
| Tigecycline once daily regimenTigecycline once-daily regimen (100 mg once daily) or (200 mg once daily). For hepatic patients with a Child-Pugh score (C), the loading dose is 100 mg, then 50 mg every 24 hours. | Drug | Tigecycline once daily regimen |
| Usual doses of tigecyclineTigecycline standard dose (100 mg loading dose then 50 mg every 12 hours) or (200 mg loading dose then 100 mg every 12 hours). For hepatic patients with Child-Pugh score (C), the loading dose is 100 mg then 25 mg every 12 hours | Drug | Control arm : Usual doses of tigecycline |
Primary outcome
Compare treatment outcomes (clinical response) of the tigecycline once-daily regimen and the standard regimen (twice-daily regimen). composite endpoint
Time frame: 28 days
Composite clinical response, defined as improvement of inflammatory markers (CRP, Procalcitonin), clinical improvement permitting ICU discharge, and absence of need to modify tigecycline therapy (no escalation or addition of other antibiotics), will be assessed at different time points during the study period. The response is classified as 1- Treatment success (Cure) by improvement of the SOFA score, improvement of infection markers ( CRP, Procalcitonin), and by the need for ICU stay ( ICU length of stay) 2- Treatment failure by an increase of SOFA score, an increase of infection markers ( CRP, Procalcitonin), need to change tigecycline to another antibiotic, or to add on another antibiotic, and death 3) Indeterminate response for drop-out patients and incomplete minimal duration of therapy
Compare the safety of the tigecycline once-daily regimen and the standard regimen (twice-daily regimen).
Time frame: 28 days
1. Tigecycline-induced hyperbilirubinemia will be assessed by comparing the baseline bilirubin level to the follow-up level at determined intervals (3 days, 5 days), allowing for comparison of the incidence of hyperbilirubinemia between the two study groups. .
4 secondary outcomes
- Intensive care unit (ICU) and in-hospital mortality between the two groups.
Time frame: 28 days
Infection markers change between the two groups (C-reactive protein (CRP)
Time frame: 28 days
Vasopressor needs (only in septic shock patients).
Time frame: 28 days
Compare the incidence of tigecycline-induced vomiting between the two groups
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Multi Drug Resistant Infections
Active, not recruitingObservational study
Investigating the Optimal Management of Dolutegravir Resistance
HIV-1-infection
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
RecruitingObservational study
Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
Multidrug-resistant Tuberculosis (MDR-TB)
RecruitingObservational study
Aztreonam-Avibactam in Immunocompromised Hosts
Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection
RecruitingPhase 1
A Phase 1 Study of the Safety and Tolerability of Single and Multiple Ascending Doses of BWC0977 in Healthy Volunteers
Infectious Diseases, Antimicrobial Drug Resistance
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tigecycline once daily regimen and Usual doses of tigecycline in people with Multi Drug Resistant Infections, run by Air Force Specialized Hospital, Cairo, Egypt at 1 site in Egypt.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 2 Dec 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Compare treatment outcomes (clinical response) of the tigecycline once-daily regimen and the standard regimen (twice-daily regimen). composite endpoint (time frame: 28 days). The study lists 2 primary outcomes in all. 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 Dec 2025.