Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2014-004906-14-Outside-EU/EEA
• Date of registration: 07/04/2015
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc
• Public title: Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa
• Scientific title: An Open Label, Non-Comparative Study To Evaluate Parasitological Clearance Rates and Pharmacokinetics of Azithromycin and Chloroquine Following Administration of a Fixed Dose Combination of Azithromycin and Chloroquine (AZCQ) in Asymptomatic Pregnant Women With Plasmodium Falciparum Parasitemia in Sub-Saharan Africa
• Target sample size: 168
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004906-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Benin, Kenya, Malawi, Tanzania, United Republic of, Uganda

Contacts

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

Key inclusion & exclusion criteria

Inclusion criteria:
1. Primigravidae and secundigravidae pregnant women at greater than or equal to (>=) 14 and less than or equal to (<=) 30 weeks of gestational age (confirmed by ultrasound examination).
2. Evidence of asymptomatic parasitemia with Plasmodium falciparum monoinfection (confirmed by microscopy) with parasite counts in the range of 80-100,000 per microliter on thick blood smears.
3. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative if a subject is less than [<] 18 years of age) has been informed of all pertinent aspects of the study and that all questions by the subject have been sufficiently answered. Assent will be obtained from subjects <18 years of age.
4. Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
5. Subjects supervised for treatment administration, and available for all follow up visits as per protocol.


Are the trial subjects under 18? yes
Number of subjects for this age range: 168
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 127
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Age <16 years old or greater than (>)35 years old.
2. Multiple gestations (more than one fetus) as per the ultrasound results at screening.
3. Clinical symptoms of malaria.
4. Hemoglobin <8 gram per deciliter (g/dL).
5. Any condition requiring hospitalization or evidence of severe concomitant infection at time of presentation.
6. Use of antimalarial drugs in previous 4 weeks.
7. History of convulsions, hypertension, diabetes or any other chronic illness that may
adversely affect fetal growth and viability.
8. Inability to tolerate oral treatment in tablet form.
9. Known allergy to the study drugs (Azithromycin [AZ], Chloroquine [CQ], and Sulfadoxine-pyrimethamine [SP]) or to any macrolides or sulphonamides.
10. Present history of smoking or alcohol or drug abuse since becoming pregnant.
11. Participation in other studies within 30 days before the current study begins and/or during study participation.
12. Inability to comprehend and/or unwillingness to follow the study protocol.
13. Concurrent participation in another investigational study.
14. Previously randomized in this study.
15. Requirement to use medication during the study that might interfere with the evaluation of the study drug (for example, trimethoprim-sulfamethoxazole use in subjects positive for HIV infection) or is contra-indicated during pregnancy per package inserts.
16. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that increase the risk associated with study participation or investigational product administration or interfer with the interpretation of study results and, made the subject inappropriate for entry into this study
17. Evidence of current obstetric complications that adversely impacted the pregnancy and/or fetal outcomes, including presence of congenital anomalies, placenta previa or abruption.
18. Known severe sickle cell (SS) disease or sickle-hemoglobin C (SC) anemia.
19. Known family history of prolonged QT syndrome, serious ventricular arrhythmia, or sudden cardiac death.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

Asymptomatic Parasitemia

Intervention(s)

Product Name: azithromycin and chloroquine
Pharmaceutical Form: Tablet
INN or Proposed INN: Azithromycin
CAS Number: 83905-01-5
Current Sponsor code: PF-06425116
Other descriptive name: AZITHROMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250 -
INN or Proposed INN: CHLOROQUINE
CAS Number: 54-05-7
Current Sponsor code: SUB06196MIG
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 155-

Primary Outcome(s)

Secondary Objective: Parasitological clearance rates (PCR corrected) at Days 7, 14, 21, 35, and 42 post first dose of study medication.
Parasitological clearance rates (PCR uncorrected) at Days 7, 14, 21, 28, 35, and 42 post first dose of study medication.
Pharmacokinetic exposure of AZCQ.
Safety and tolerability of AZCQ

Main Objective: To evaluate the peripheral parasitological clearance rate of Azithromycin/chloroquine (AZCQ) on Day 28 (Polymerase chain-reaction [PCR] corrected) following first dose of 3-day dosing regimen of AZCQ in asymptomatic pregnant women with Plasmodium falciparum parasitemia.

Primary end point(s): Percentage of Subjects With Parasitological Response (PCR corrected) at Day 28

Timepoint(s) of evaluation of this end point: Day 28

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Day 7, 14, 21, 35, and 42
Days 7, 14, 21, 28, 35, and 42

Secondary end point(s): Percentage of Subjects With Parasitological Response (PCR corrected) Day 7, 14, 21, 35, and 42
Percentage of Subjects With Parasitological Response (PCR uncorrected) Days 7, 14, 21, 28, 35, and 42
Plasmodium falciparum Parasite Count Days 7, 14, 21, 28, 35, and 42

Secondary ID(s)

A0661201

NCT01103713

Source(s) of Monetary Support

Pfizer Inc