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IRCT20260518069437N1 IRCT 2026-08-02 Ahvaz University of Medical Sciences Comparison of treatment methods for microbial infection in patients with meningitis. Evaluation of the effectiveness of intrathecal versus intraventricular antimicrobial therapy for bacterial meningitis following craniotomy: a clinical trial 2026-08-08 anticipated 30 Recruiting https://irct.ir/trial/91479 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization will be used to allocate patients to two parallel groups (intrathecal versus intraventricular therapy) with a 1:1 allocation ratio. The randomization unit is the individual patient. Random allocation will be performed using a computer-generated random number table to ensure that each participant has an equal probability of being assigned to either study arm. To implement this, sequentially numbered, opaque, sealed envelopes (SNOSE) containing the group assignments (odd numbers for the intrathecal group and even numbers for the intraventricular group) will be prepared. Upon enrollment and after obtaining informed consent, the coordinator will open the corresponding envelope in sequence. The allocation sequence will be concealed from both the principal investigators and the outcome assessors. Potential confounding factors, including the presence of an external ventricular drain (EVD), primary indication for craniotomy, age, gender, and underlying comorbidities, will be controlled during the data analysis stage using stratification or multivariate regression models, Blinding description: Due to the nature of the intervention, blinding of participants and healthcare providers (physicians and nurses involved in delivering the intervention) is not feasible; therefore, they will be aware of group allocation. However, blinding will be implemented at the level of outcome assessment and data analysis. Outcome assessors responsible for data collection and outcome recording will be blinded to group allocation and will only identify participants using coded labels (A and B). In addition, the statistician performing data analysis will be blinded to treatment allocation, and all analyses will be conducted using anonymized and coded datasets without access to intervention-related information. 3 Meningitis. Intervention 1: Intervention group: Intravenous treatment: 2 g of meropenem every 8 hours if the culture result is gram-negative, and 1 g of vancomycin every 12 hours if the culture result is gram-positive. In addition to the intravenous treatment mentioned above, intracranial treatment is also given with 125 units of colistin daily if the culture result is gram-negative, and 80 g of vancomycin daily if the culture result is gram-positive. Empirical treatment, including ceftazidime and vancomycin twice daily or according to the results of the Gram stain, will be given. Definitive treatment is determined based on sensitivities, with a preference for narrow-spectrum beta-lactams. Treatment will continue until definitive improvement is confirmed based on laboratory culture results. Intervention 2: Control group: Intravenous treatment is 2 g of meropenem every 8 hours if the culture result is gram-negative, and 1 g of vancomycin every 12 hours if the culture result is gram-positive. Empirical treatment includes ceftazidime and vancomycin twice a day or according to the results of the Gram stain. Definitive treatment is determined based on sensitivities, with a preference for narrow-spectrum beta-lactams. Treatment is continued until definitive improvement based on laboratory culture results. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Armin Jahangiri Babadi
Department of Neurosurgery, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 912 440 1022 jahangiribabadi-a@ajums.ac.ir Ahvaz University of Medical Sciences scientific Armin Jahangiri Babadi
Department of Neurosurgery, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 912 440 1022 jahangiribabadi-a@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients aged 16-80 years with meningitis caused by gram-negative bacteria after craniotomy Concurrent or in-hospital external ventricular drain (EVD) infection Patient consent to participate in the study 20 years no limit Both History of shunting Previous brain or spinal surgery Recent antibiotic use Sensitivity to study drugs Renal dysfunction Death during the study A87.9 Viral meningitis, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Intravenous treatment: 2 g of meropenem every 8 hours if the culture result is gram-negative, and 1 g of vancomycin every 12 hours if the culture result is gram-positive. In addition to the intravenous treatment mentioned above, intracranial treatment is also given with 125 units of colistin daily if the culture result is gram-negative, and 80 g of vancomycin daily if the culture result is gram-positive. Empirical treatment, including ceftazidime and vancomycin twice daily or according to the results of the Gram stain, will be given. Definitive treatment is determined based on sensitivities, with a preference for narrow-spectrum beta-lactams. Treatment will continue until definitive improvement is confirmed based on laboratory culture results. Control group: Intravenous treatment is 2 g of meropenem every 8 hours if the culture result is gram-negative, and 1 g of vancomycin every 12 hours if the culture result is gram-positive. Empirical treatment includes ceftazidime and vancomycin twice a day or according to the results of the Gram stain. Definitive treatment is determined based on sensitivities, with a preference for narrow-spectrum beta-lactams. Treatment is continued until definitive improvement based on laboratory culture results. Positive blood culture. Timepoint: In time of treatment initiation up to discharge time. Method of measurement: Culture of blood sample in the laboratory. Need to tracheostomy. Timepoint: Every day following treatment initiation. Method of measurement: To perform or not to perform a tracheostomy. Mortality. Timepoint: 14 days following treatment initiation. Method of measurement: Alive or expired. Duration of admission in ICU. Timepoint: The day of discharge from ICU. Method of measurement: Day count. The time of blood culture results to be positive. Timepoint: In time of treatment initiation up to discharge time. Method of measurement: Day count. CSF biochemistry smear. Timepoint: In time of treatment initiation up to discharge time. Method of measurement: Laboratory assessment. Neurological deterioration. Timepoint: Every day following treatment initiation. Method of measurement: Brain imaging. Mortality. Timepoint: 30 days following treatment initiation. Method of measurement: Alive or expired. Ahvaz University of Medical Sciences Approved 2026-06-27 Ethical Committee of Ahvaz Jundishapur University of Medical Sciences Second Floor, Research Vice-Chancellor Building, Ahvaz Jundishapur University, Golestan Highway, Iran ahvaz Khouzestan Iran (Islamic Republic of)