NCT01603732 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Eghtesady P
Hypoplastic left heart syndrome: Rheumatic heart disease of the fetus? Med Hypotheses. 2006;66(3):554-65. Epub 2005 Oct 20.
McGregor KF, Spratt BG, Kalia A, Bennett A, Bilek N, Beall B, Bessen DE
Multilocus sequence typing of Streptococcus pyogenes representing most known emm types and distinctions among subpopulation genetic structures. J Bacteriol. 2004 Jul;186(13):4285-94.

Evaluation of Maternal B-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease(CHD)

Clinical trial NCT01603732 - References