NCT06123780

Brief Summary

Measurement of bacterial species causing AECOPD and their Sensitivity pattern to antibiotics.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

October 11, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

October 11, 2023

Last Update Submit

November 21, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pattern of Microbial infection based on sputum culture results.

    Identification of causative Microbial organisms of AECOPD based on results of sputum culture.

    Baseline

  • Pattern of antimicrobial sensitivities based on sputum culture results.

    Identification of antimicrobial sensitivities and resistance patterns in this population based on results of sputum culture.

    Baseline

Secondary Outcomes (1)

  • Hospital length of stay

    Baseline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Demographic characteristics of these patients will be recorded, including sex, age, smoking status, underlying comorbidities, occupation and number of exacerbations. Clinical features will be recorded including increase grade of dyspnea , purulence and amount of sputum , history of previous NIV or MV. Spirometry as a confirmation tool of COPD. Arterial blood gases on admission. Complete blood count ( CBC ) and ESR Radiological profile of COPD patients. Sputum sample ; Spontaneous sputum sample by asking the patient to cough up sputum into sterile container. NIV patients : by spontaneous sputum sample. MV patients : by sputum suction through the endotracheal tube .

You may qualify if:

  • Must be at least 18 years of age and less than 80 years of age for both genders
  • Confirmed diagnosis of COPD by spirometry
  • Must be an AECOPD patient (with increased grade of dyspnea, increased purulence and amount of sputum) and admitted to the chest department or ICU
  • Positive sputum culture

You may not qualify if:

  • Age less than 18 years old
  • Any associated pulmonary co-morbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Venkatesan P. GOLD report: 2022 update. Lancet Respir Med. 2022 Feb;10(2):e20. doi: 10.1016/S2213-2600(21)00561-0. Epub 2021 Dec 20. No abstract available.

    PMID: 34942084BACKGROUND
  • Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest. 2000 May;117(5 Suppl 2):398S-401S. doi: 10.1378/chest.117.5_suppl_2.398s.

    PMID: 10843984BACKGROUND
  • Sethi S, Murphy TF. Infection in the pathogenesis and course of chronic obstructive pulmonary disease. N Engl J Med. 2008 Nov 27;359(22):2355-65. doi: 10.1056/NEJMra0800353. No abstract available.

    PMID: 19038881BACKGROUND
  • Momanyi L, Opanga S, Nyamu D, Oluka M, Kurdi A, Godman B. Antibiotic Prescribing Patterns at a Leading Referral Hospital in Kenya: A Point Prevalence Survey. J Res Pharm Pract. 2019 Oct 16;8(3):149-154. doi: 10.4103/jrpp.JRPP_18_68. eCollection 2019 Jul-Sep.

    PMID: 31728346BACKGROUND
  • Slone DE, Ganjam VK, Purohit RC, Ravis WR. Cortisol (hydrocortisone) disappearance rate and pathophysiologic changes after bilateral adrenalectomy in equids. Am J Vet Res. 1983 Feb;44(2):276-9.

    PMID: 6830017BACKGROUND

Study Officials

  • Khaled H. Ahmed, Professor

    Assuit U

    STUDY DIRECTOR
  • Samiaa H Sadek, Professor

    Assuit U

    STUDY DIRECTOR

Central Study Contacts

Mariam Nazif Abdel-Tawab, MD

CONTACT

Ahmed H Mohammed, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

October 11, 2023

First Posted

November 9, 2023

Study Start

December 1, 2023

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11