NCT00001101 - 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)

Klempner M, Hu L, Johnson G
Severe physical disability and other characteristics in patients with post treatment chronic Lyme disease. VIII International Conference on Lyme Borreliosis and other Emerging Tick-Borne Diseases, Munich, Germany June 20-24, 1999.
Klempner MS, Hu LT, Evans J, Schmid CH, Johnson GM, Trevino RP, Norton D, Levy L, Wall D, McCall J, Kosinski M, Weinstein A
Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. N Engl J Med. 2001 Jul 12;345(2):85-92.
Klempner MS, Schmid CH, Hu L, Steere AC, Johnson G, McCloud B, Noring R, Weinstein A
Intralaboratory reliability of serologic and urine testing for Lyme disease. Am J Med. 2001 Feb 15;110(3):217-9.
Perides G, Charness ME, Tanner LM, Péter O, Satz N, Steere AC, Klempner MS
Matrix metalloproteinases in the cerebrospinal fluid of patients with Lyme neuroborreliosis. J Infect Dis. 1998 Feb;177(2):401-8.

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seropositive Chronic Lyme Disease

Details for clinical trial NCT00001101

Clinical trial NCT00001101 - References