Aciclovir for HSV-2 MENingitis: A double-blinded randomised controlled trial (AMEN)

Conditions

HSV-2 meningitis

Brief summary

The primary outcome in the current study is the proportion of patients with a TMS >6 at 7 days since randomisation.

Detailed description

Proportion of patients with ≤50% reduction in TMS score after 7 days compared with TMS score at randomisation, Unfavourable outcome (E-GOS <7) and all-cause mortality at 7 days, 3 and 12 months since randomisation, Proportion with a headache score of >2 at 7 days since randomisation, Persisting neurological symptoms (sensory or motor nerve) at 7 days, 3 and 12 months since randomisation, Completion of assigned treatment strategy, Peripheral venous line complications (infection or superficial venous thrombosis) during treatment, Duration of admission, Severe adverse events during treatment, Quality of life scores and cognitive evaluations (SF-36, EQ-5D-5L, Mental fatigue Scale) at 7 days as well as 3- and 12-months since randomisation

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGIV and tablet placebo identifical to the active products will be produced by: Euromed Pharma Services S.R.L. Via Abruzzi snc

DRUG20056 Grezzago

DRUGItaly www.euromed-pharma.com

DRUGAciclovir Pfizer 25 mg/ml

DRUGkoncentrat till infusionsvätska

DRUGlösning

DRUGValaciclovir Sandoz 500 mg compresse rivestite con film

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary outcome in the current study is the proportion of patients with a TMS >6 at 7 days since randomisation.	—

Secondary

Measure	Time frame
Proportion of patients with ≤50% reduction in TMS score after 7 days compared with TMS score at randomisation, Unfavourable outcome (E-GOS <7) and all-cause mortality at 7 days, 3 and 12 months since randomisation, Proportion with a headache score of >2 at 7 days since randomisation, Persisting neurological symptoms (sensory or motor nerve) at 7 days, 3 and 12 months since randomisation, Completion of assigned treatment strategy, Peripheral venous line complications (infection or superficial venous thrombosis) during treatment, Duration of admission, Severe adverse events during treatment, Quality of life scores and cognitive evaluations (SF-36, EQ-5D-5L, Mental fatigue Scale) at 7 days as well as 3- and 12-months since randomisation	—

Measure

Time frame

Proportion of patients with ≤50% reduction in TMS score after 7 days compared with TMS score at randomisation, Unfavourable outcome (E-GOS <7) and all-cause mortality at 7 days, 3 and 12 months since randomisation, Proportion with a headache score of >2 at 7 days since randomisation, Persisting neurological symptoms (sensory or motor nerve) at 7 days, 3 and 12 months since randomisation, Completion of assigned treatment strategy, Peripheral venous line complications (infection or superficial venous thrombosis) during treatment, Duration of admission, Severe adverse events during treatment, Quality of life scores and cognitive evaluations (SF-36, EQ-5D-5L, Mental fatigue Scale) at 7 days as well as 3- and 12-months since randomisation

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Countries

Denmark

Outcome results

None listed