Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Desmopressin.

It had three arms (groups): 1 (no intervention), 2 (experimental) and 3 (experimental).

Standard supportive care.

Dexamethasone treatment.

Desmopressin treatment.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 64 actual participants took part.

It was open to people of any sex aged from 15 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult patients (\> 14 years) with suspected severe leptospirosis. Patients who presented with acute fever (oral temperature more than 38.00 C for \<15 days) in the absence of an obvious focus of infection. In the opinion of the attending physician might have pulmonary hemorrhage (i.e. history of hemoptysis, and/ or bilateral nodular or air space infiltration).

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: pregnant or breastfeeding; those with history of bleeding disorder; those who had underlying diseases such as chronic liver disease, diabetes mellitus.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Desmopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Desmopressin study: the participants and staff both knew the treatment.

It started in 2003-07 with completion listed for 2006-10.

It ran at 1 site in Thailand.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Survival (time frame: during in hospital admission).

It also tracked 1 secondary outcome, for example Days of mechanical ventilation.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Desmopressin in 64 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.