Phase 2
Completed N=110
A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria
Falciparum Malaria
Source: ClinicalTrials.gov NCT00282919 ↗
Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Percentage of Participants With Parasite Clearance at Day 28 — 97.20 percentage of participants
Summary
The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Parasite Clearance at Day 28 |
97.20 | — |
| SECONDARY Percentage of Participants With Early Treatment Failures (ETF) |
— | — |
| SECONDARY Percentage of Participants With Late Treatment Failures (LTF) |
2.80 | — |
| SECONDARY Percentage of Participants With Resistance to Treatment |
22.02; 22.02; 22.43; 24.3; 25.23; 25.23 | — |
| SECONDARY Percentage of Participants With Clinical Cure |
100.00; 100.00; 96.33; 96.33 | — |
| SECONDARY Percentage of Participants With Parasite Clearance at Day 7, 14, 21, 35, 42 |
100.00; 100.00; 99.07; 96.26; 96.26 | — |
| SECONDARY Percentage of Participants With Gametocyte Clearance |
84.40; 81.65; 77.35; 76.19; 76.69; 76.92 | — |
| SECONDARY Fever Clearance Time |
— | — |
| SECONDARY Parasite Clearance Time |
— | — |
Eligibility Criteria
Inclusion Criteria
- Males and females greater then or equal to the age of 18 with uncomplicated, symptomatic malaria as indicated by the presence of blood smears positive for P. falciparum asexual parasitemia between 1000-100,000 parasites/uL and documented fever greater then or equal to 38.5 C/101.3 F rectal or fever greater then or equal to 38 C/100.4 F oral or history of fever as reported by subject within the prior 24 hours.
Exclusion Criteria
- Subjects with severe or complicated malaria. Pregnant or breast feeding women.
Data sourced from ClinicalTrials.gov (NCT00282919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.