Wound SepsisPhase 4NCT04062175
Efficacy of Adding Azithromycin to Cephalosporin Before Cesarean Delivery
A Phase 4 study testing cephalosporin and Azithromycin Tablets in people with Wound Sepsis, run by Ain Shams University at 1 site in Egypt.
Trial summary
efficacy of adding azithromycin to cephalosporin before cesarean delivery Read more about this study
- Who is it for?
- Ages 17 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wound Sepsis
- What is being tested?
- cephalosporin and Azithromycin Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2019to 18 Jul 2019
- 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 17 to 39 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age between 17 and 39 years
- gestaional age between 37 to 42 weeks
- elective cesarean delivery
- obese women
Who cannot join
- diabetic women on corticosteroids
- intraopertaive complication in previous section
- history of septic woun
- prelabour rupture of membrane >12 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Adding Azithromycin to Cephalosporin for the Prophylaxis Against Infectious Morbidity Following Cesarean Delivery in High Risk Women
efficacy of adding azithromycin to cephalosporin before cesarean delivery
Read the detailed description
efficacy of adding azithromycin to cephalosporin for the prophylaxis against infectious morbidity following cesarean delivery in high risk women
- Conditions
- Wound Sepsis
- Being tested
- cephalosporin, Azithromycin Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cephalosporinDrug
72 women will receive single antibiotic chemotherapy(Cefazolin) 2 gm iv within 30 minutes before skin incision
Azithromycin TabletsDrug
72 women will receive combined antibiotic chemotherapy azithromycin(Azrolid) 1 gm single oral dose 2 hours before cesarean delivery +cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision
| Study group | Role | What they receive |
|---|---|---|
| cephalosporin arm | Active comparator | 72 women will receive single antibiotic chemotheraby first generation cephalosporin (cefazolin) 2 gm iv within 30 minutes before skin incision Receives: Drug: cephalosporin |
| cephalosporin +azithromycin arm | Active comparator | 72 women will receive combined antibiotic chemotherapy azithromycin (Azrolid) 1 gm single oral dose 2 hours before cesarean delivery + cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision Receives: Drug: cephalosporin; Drug: Azithromycin Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of women with wound infection
superficial and deep surgical site wound infection will be looked for by laboratory confirmation
Measured: after 14 days post cesarean delivery
Secondary outcomes (1)
% of women with postpartum endometritis
fever, abdominal pain , uterine tenderness will be looked for
Measured: after 14 days post cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start20 Mar 2019
- Primary completion20 Jun 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound SepsisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada fayed hashem el sharkawy, Ain Shams University
- Investigators
- Reda Mokhtar, MD, Principal investigator, AinShams university ,egypt el abbasia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062175
- Sponsor's protocol ID
- 55
- Status last verified
- Aug 2019
- First submitted
- 13 Aug 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Azithromycin to Cephalosporin for the Prophylaxis Against Infectious Morbidity Following Cesarean Delivery in High Risk Women
- ClinicalTrials.gov ID
- NCT04062175
- Acronym / sponsor ID
- 55
- Conditions
- Wound Sepsis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 20 Aug 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.
efficacy of adding azithromycin to cephalosporin before cesarean delivery
Detailed description
efficacy of adding azithromycin to cephalosporin for the prophylaxis against infectious morbidity following cesarean delivery in high risk women
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cephalosporin arm | Active comparator | Drug: cephalosporin72 women will receive single antibiotic chemotheraby first generation cephalosporin (cefazolin) 2 gm iv within 30 minutes before skin incision |
| cephalosporin +azithromycin arm | Active comparator | Drug: cephalosporin, Drug: Azithromycin Tablets72 women will receive combined antibiotic chemotherapy azithromycin (Azrolid) 1 gm single oral dose 2 hours before cesarean delivery + cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision |
Who may qualify
- Ages
- 17 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- age between 17 and 39 years
- gestaional age between 37 to 42 weeks
- elective cesarean delivery
- obese women
Key exclusion criteria (4 listed)
- diabetic women on corticosteroids
- intraopertaive complication in previous section
- history of septic woun
- prelabour rupture of membrane >12 hours
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 |
|---|---|---|
| cephalosporin72 women will receive single antibiotic chemotherapy(Cefazolin) 2 gm iv within 30 minutes before skin incision | Drug | cephalosporin +azithromycin arm, cephalosporin arm |
| Azithromycin Tablets72 women will receive combined antibiotic chemotherapy azithromycin(Azrolid) 1 gm single oral dose 2 hours before cesarean delivery +cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision | Drug | cephalosporin +azithromycin arm |
Primary outcome
% of women with wound infection
Time frame: after 14 days post cesarean delivery
superficial and deep surgical site wound infection will be looked for by laboratory confirmation
1 secondary outcome
% of women with postpartum endometritis
Time frame: after 14 days post cesarean delivery
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 20 Aug 2019.
- 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.
Reda Mokhtar, MD principal investigator
AinShams university ,egypt el abbasia
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 cephalosporin and Azithromycin Tablets in people with Wound Sepsis, run by Ain Shams University 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 4 inclusion and 4 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 20 Aug 2019. 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?
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?
% of women with wound infection (time frame: after 14 days post cesarean delivery). 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 20 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.