The patient will received a combination of 3 antibiotics :
Rifampicin (10mg/kg once daily)
Ethambutol (15 to 20 mg/kg once daily)
Clarithromycin (500 mg twice daily)

The patient will received a combination of 3 antibiotics :
Rifampicin (10mg/kg once daily)
Ethambutol (15 to 20 mg/kg once daily)
Azithromycin (250 mg once daily)

Lung Infection

Mycobacterium Avium Complex

The patient will be received for at least 12 months, a daily antibiotic treatment who is a combination of Clarithromycin, Ethambutol and Rifampicin.

Clarithromycin 1000 MG

The patient will be received for at least 12 months, a daily antibiotic treatment who is a combination of Azithromycin, Ethambutol and Rifampicin.

Azithromycin 250 mg

The patient will be received for at least 12 months, a dailty antibiotic treatment who is a combination of Azithromycin or Clarithromycin (according to the randomisation), Ethambutol and Rifampicin.

Rifampicin

Ethambutol

CHU Amiens Picardie

Saint Joseph Hospital

CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections

Three spontaneous sputum specimens will be obtained at baseline and 6 months. If it's not possible to obtain good quality specimens, the clinician may perform three hypertonic aerosol-induced sputum specimens on 3 consecutive days. In the absence of sputum (spontaneous or induced), bronchoscopic aspiration and two post-bronchoscopy sputum specimens will be performed.
Microscopic examination will be performed after auramine or Ziehl-Neelsen stain.
Specimens will be cultured at 37°C after decontamination on Lowenstein-Jensen solid medium and Coletsos medium. Results will be expressed quantitatively as the number of colonies per tube according to a logarithmic scale. Culture on liquid medium will also be performed.
The analysis will be based on the Mycobacteria National Reference Centre microscopy, culture and antibiotic susceptibility test results.

Several criteria will be determined at baseline and at 3 months and then compared to assess clinical improvement :
Presence or absence of cough, sputum, dyspnoea, chest pain and wheezing using a 5-point analogue scale (0=no symptom, 4=permanent symptoms) ;
WHO performance status scored from 0 to 4 ;
Global score from 0 to 24, taking into account the score of the 5 respiratory symptoms and the WHO performance status ;
Presence of blood-stained sputum (haemoptysis greater than 50 mL or requiring specialized medical intervention)
Weight in kg (patient weighed in underwear on the same scales, variations taken into account when greater than 5% of the baseline weight).

Several criteria will be determined at baseline and at 6 months and then compared to assess clinical improvement :
Presence or absence of cough, sputum, dyspnoea, chest pain and wheezing using a 5-point analogue scale (0=no symptom, 4=permanent symptoms) ;
WHO performance status scored from 0 to 4 ;
Global score from 0 to 24, taking into account the score of the 5 respiratory symptoms and the WHO performance status ;
Presence of blood-stained sputum (haemoptysis greater than 50 mL or requiring specialized medical intervention)
Weight in kg (patient weighed in underwear on the same scales, variations taken into account when greater than 5% of the baseline weight).

Several criteria will be determined at baseline and at 12 months and then compared to assess clinical improvement :
Presence or absence of cough, sputum, dyspnoea, chest pain and wheezing using a 5-point analogue scale (0=no symptom, 4=permanent symptoms) ;
WHO performance status scored from 0 to 4 ;
Global score from 0 to 24, taking into account the score of the 5 respiratory symptoms and the WHO performance status ;
Presence of blood-stained sputum (haemoptysis greater than 50 mL or requiring specialized medical intervention)
Weight in kg (patient weighed in underwear on the same scales, variations taken into account when greater than 5% of the baseline weight).

Chest x-ray will be realised at baseline and at 3 months and described according to :
type of lesion: opacity/solitary pulmonary nodule, excavated opacity/ fibrocavitary disease, interstitial syndrome (multiple nodule, dense airspace disease)
precise site (upper lobe, right middle or lower lobe, left lower or upper lobe)

Chest x-ray and chest high-resolution CT will be realised at baseline and at 6 months.
Chest x-ray will be described according to:
type of lesion: opacity/solitary pulmonary nodule, excavated opacity/ fibrocavitary disease, interstitial syndrome (multiple nodule, dense airspace disease)
precise site (upper lobe, right middle or lower lobe, left lower or upper lobe)
Chest CT will be described according to:
type of lesion: nodules, micronodules, bronchiectasis, mass, interstitial syndrome (and its type)
precise site of the segment(s) involved
number of lesions
dimensions of the various lesions (long and short axes) and volume, whenever possible.

Chest x-ray and chest high-resolution CT will be realised at baseline and at 12 months.
Chest x-ray will be described according to:
type of lesion: opacity/solitary pulmonary nodule, excavated opacity/ fibrocavitary disease, interstitial syndrome (multiple nodule, dense airspace disease)
precise site (upper lobe, right middle or lower lobe, left lower or upper lobe)
Chest CT will be described according to:
type of lesion: nodules, micronodules, bronchiectasis, mass, interstitial syndrome (and its type)
precise site of the segment(s) involved
number of lesions
dimensions of the various lesions (long and short axes) and volume, whenever possible.

Microbiological specimens, preferably 3 sputum specimens, will be obtained and processed at 3 months after treatment according to the same modalities as at baseline.

Microbiological specimens, preferably 3 sputum specimens, will be obtained and processed at 12 months after treatment according to the same modalities as at baseline.

The 12-month mortality will be determined by the survival at that date. The date of any death occurring during treatment will be recorded and the interval between the start of treatment and death will be calculated. The cause of death will be investigated and reported.

All adverse events will be notified according to the recommendations. Particular attention will be paid to gastrointestinal adverse effects (the incidence of nausea and vomiting will be recorded). These adverse events will be assessed at each visit according to the Rhodes scale.
Haematological, gastrointestinal and renal toxicities will be scored according to the WHO toxicity scale.

Centre Hospitalier Universitaire, Amiens

Subjects in group A get citicoline 1000 mg per day for 60 days

Subjects in group B get placebo for 60 days.

Non-arteritic Anterior Ischemic Optic Neuropathy

Citicoline 1000 mg will be repackaged and given to Group A for 60 days

Group A Citicoline 1000 mg oral tablet

Placebo will be repackaged and given to Group B for 60 days

Group B placebo oral tablet

Departemen Mata Fakultas Kedokteran Universitas Indonesia- RSCM Kirana

Citicoline Effect on Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

Citicoline Effect on Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) : Pattern Electroretinography Study

amplitude measured from the valley of N35 to the peak of P50 with pattern electroretinography

amplitude measured from peak of P50 to valley of N95 with pattern electroretinography

anatomical cross-sectional examination of retinal ganglion cells using optical coherence tomography (OCT) CirrusTM HD-OCT 5000. The mode is panomap ganglion cell analysis: Macular Cube 512x128 and 200x200 cube Optic disc. Examination is repeated with minimal attention to signal strength is ≥ 5.

visual field test results using Humphrey HFA II-i 750, 24-2 threshold. Examination is repeated by taking into account the confidence index that meets the three criteria below:
Fixation losses ≤ 20%
False positive ≤ 15%
False negative ≤ 20-30%
The parameters assessed are:
The mean deviation (MD): the result of the average sensitivity of the retina of patients compared with the normal population. This figure is obtained from the total deviation.
Pattern standard deviation (PSD): the result of the average sensitivity of the retina of patients who have adapted and showed a localized area index. This figure is obtained from the pattern deviation.

Valen Chia

dr. Valenchia

Sample of 20 people for each treatment group (Group A: citicoline and group B : placebo). Both group were given drug (whether citicoline or placebo) for 60 days.

The allocation of the subject is done by using block randomization. Randomization will be performed by a third party before the study began. Number randomization results will be incorporated into the white envelope sealed and classified into group A (got citcoline) or group B (placebo) in accordance with the results of randomization. Neither the participant, investigator nor the outcome assessor know whether the patient is classified into group A or B.

uveitis/zvracení

CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections

Citicoline Effect on Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

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